Apparatus and methods for receiving discharged urine

ABSTRACT

A system suitable for collecting and transporting urine away from the body of a person or animal may include an assembly having a fluid impermeable casing having a fluid reservoir at a first end, a fluid outlet at a second end, and a longitudinally extending fluid impermeable layer coupled to the fluid reservoir and the fluid outlet and defining a longitudinally elongated opening between the reservoir and the outlet. The assembly can further include a fluid permeable support disposed within the casing with a portion extending across the elongated opening, and a fluid permeable membrane disposed on the support and covering at least the portion of the support that extends across the elongated opening, so that the membrane is supported on the support and disposed across the elongated opening. The assembly can further include a tube having a first end disposed in the reservoir and a second, fluid discharge end.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. PatentApplication No. 62/414,963, filed Oct. 31, 2016, entitled “Apparatus andMethods for Receiving Discharged Urine,” and U.S. Patent Application No.62/485,578, filed Apr. 14, 2017, entitled “Apparatus and Methods forReceiving Discharged Urine,” the disclosures of which are incorporatedherein by reference in their entirety.

This application also is a continuation-in-part of and claims priorityto and the benefit of U.S. patent application Ser. No. 15/260,103, filedSep. 8, 2016, entitled “Apparatus and Methods for Receiving DischargedUrine,” which is a continuation of and claims priority to PCT PatentApplication No. PCT/US2016/049274, filed Aug. 29, 2016, entitled“Apparatus and Methods for Receiving Discharged Urine, which is acontinuation-in-part of and claims priority to and the benefit of U.S.patent application Ser. No. 15/171,968, filed Jun. 2, 2016, entitled“Using Wicking Material To Collect Liquid For Transport,” thedisclosures of which are incorporated herein by reference in theirentirety.

U.S. patent application Ser. No. 15/260,103 is also acontinuation-in-part of and claims priority to and the benefit of U.S.patent application Ser. No. 14/952,591, filed Nov. 25, 2015, entitled“Container for Collecting Liquid for Transport,” which claims priorityto and the benefit of U.S. Patent Application No. 62/084,078, filed Nov.25, 2014, entitled “Container for Collecting Liquid for Transport,” thedisclosures of which are incorporated herein by reference in theirentirety.

U.S. patent application Ser. No. 15/260,103 is also acontinuation-in-part of and claims priority to and the benefit of U.S.patent application Ser. No. 14/947,759, filed Nov. 20, 2015, entitled“Stabilizing Disposition of Moisture-Wicking Article Portion of a UrineCollection Device During Use of the Device,” which claims priority toand the benefit of U.S. Patent Application No. 62/082,279, filed Nov.20, 2014, entitled “Stabilizing Disposition of Moisture-Wicking ArticlePortion of a Urine Collection Device During Use of the Device,” thedisclosures of which are incorporated herein by reference in theirentirety.

U.S. patent application Ser. No. 15/260,103 is also acontinuation-in-part of and claims priority to and the benefit of U.S.patent application Ser. No. 14/625,469, filed Feb. 18, 2015, entitled“Urine Collection Apparatus and Related Methods,” which claims priorityto and the benefit of U.S. Patent Application No. 61/955,537, filed Mar.19, 2014, entitled “Urine Collection Apparatus and Related Methods,” thedisclosures of which are incorporated herein by reference in theirentirety.

TECHNICAL FIELD

The present disclosure relates generally to systems, apparatus, andmethods for collecting and transporting urine away from the body of aperson or animal.

BACKGROUND

The embodiments described herein relate generally to collecting andtransporting urine away from the body of a person or animal. In variouscircumstances, a person or animal may have limited or impaired mobilitysuch that typical urination processes are challenging or impossible. Forexample, a person may experience or have a disability that impairsmobility. A person may have restricted travel conditions such as thoseexperienced by pilots, drivers, and workers in hazardous areas.Additionally, sometimes urine collection is needed for monitoringpurposes or clinical testing.

Urinary catheters, such as a Foley catheter, can be used to address someof these circumstances, such as incontinence. Unfortunately, however,urinary catheters can be uncomfortable, painful, and can lead tocomplications, such as infections. Additionally, bed pans, which arereceptacles used for the toileting of bedridden patients, such as thosein a health care facility, are sometimes used. Bed pans, however, can beprone to discomfort, spills, and other hygiene issues.

Thus, there is a need for a device capable of collecting urine from aperson or animal comfortably and with minimal contamination of the userand/or the surrounding area.

SUMMARY

A system is disclosed that is suitable for collecting and transportingurine away from the body of a person or animal. The disclosed systemincludes an assembly that may include a fluid impermeable casing havinga fluid reservoir at a first end, a fluid outlet at a second end, and alongitudinally extending fluid impermeable layer coupled to the fluidreservoir and the fluid outlet and defining a longitudinally elongatedopening between the fluid reservoir and the fluid outlet. The assemblycan further include a fluid permeable support disposed within the casingwith a portion extending across the elongated opening, and a fluidpermeable membrane disposed on the support and covering at least theportion of the support that extends across the elongated opening, sothat the membrane is supported on the support and disposed across theelongated opening. The assembly can further include a tube having afirst end disposed in the reservoir and extending behind at least theportion of the support and the portion of the membrane disposed acrossthe elongated opening and extending through the fluid outlet to asecond, fluid discharge end. The assembly can be configured to bedisposed with the opening adjacent to a urethral opening of a user, toreceive urine discharged from the urethral opening through the openingof the fluid impermeable layer, the membrane, the support, and into thereservoir, and to have the received urine withdrawn from the reservoirvia the tube and out of the fluid discharge end of the tube.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic block diagram of a system, according to anembodiment.

FIG. 2 is a perspective view of an assembly with a portion of theassembly shown in cut away, according to an embodiment.

FIG. 3 is a perspective view of the assembly of FIG. 2 including apermeable membrane.

FIG. 4 is a schematic illustration of the assembly of FIG. 2 as part ofa system.

FIG. 5 is a schematic illustration of a system, according to anembodiment.

FIG. 6A is front view of an assembly, according to an embodiment.

FIG. 6B is front view of an assembly, according to an embodiment.

FIG. 6C is front view of an assembly, according to an embodiment.

FIG. 7 is a perspective view of an assembly with a portion of theassembly shown in cut away, according to an embodiment.

FIG. 8 is a perspective view of an assembly, according to an embodiment.

FIG. 9 is a perspective view of the assembly of FIG. 8 including apermeable membrane, according to an embodiment.

FIG. 10 is a perspective view of a first end of a permeable support,according to an embodiment.

FIG. 11 is a perspective view of a second end of a permeable support,according to an embodiment.

FIG. 12 is a perspective view of a first end cap, according to anembodiment.

FIG. 13 is a perspective view of a second end cap, according to anembodiment.

FIG. 14 is a schematic illustration of a urine test strip in a portionof tubing line, according to an embodiment.

FIG. 15 is a perspective view of an assembly, according to anembodiment.

FIG. 16 is a perspective view of a permeable support, according to anembodiment.

FIG. 17 is a cross-sectional view of the permeable support of FIG. 16taken along line 17-17.

FIG. 18 is a side view of an assembly including the permeable support ofFIG. 16, according to an embodiment.

FIG. 19 is a perspective view of a permeable support, according to anembodiment.

FIG. 20 is a cross-sectional view of the permeable support of FIG. 19taken along line 20-20.

FIG. 21 is a side view of an assembly including the permeable support ofFIG. 19, according to an embodiment.

FIGS. 22-24 are front, back, and side views of an assembly,respectively, according to an embodiment.

FIG. 25 is a side view of the assembly of FIG. 22 including animpermeable backing.

FIG. 26 is a front view of the assembly of FIG. 22 including a permeablemembrane.

FIG. 27 is a top view of an impermeable casing, according to anembodiment.

FIG. 28 is a cross-sectional side view of the impermeable casing of FIG.27 taken along line 28-28.

FIG. 29 is a top view of a permeable support in a first configuration,according to an embodiment.

FIG. 30 is a perspective view of the permeable support of FIG. 29 in asecond configuration.

FIG. 31 is a perspective view of the permeable support of FIG. 29 with apermeable membrane.

FIG. 32 is a cross-sectional side view of an assembly, according to anembodiment.

FIG. 33 is a cross-sectional side view of the assembly of FIG. 32engaged with a female body.

FIG. 34 is an exploded view of an assembly, according to an embodiment.

FIG. 35 is a side view of the assembly of FIG. 34 in an assembledconfiguration.

FIG. 36 is an exploded view of a portion of an assembly, according to anembodiment.

FIG. 37 is a top view of a partially assembled configuration of theassembly of FIG. 36.

FIG. 38 is a side view of the assembly of FIG. 36 in an assembledconfiguration.

FIG. 39 is a flowchart illustrating a method of using an assembly tocollect urine from a user, according to an embodiment.

FIG. 40 is a back view of an impermeable casing including a vacuumrelief opening, according to an embodiment.

FIG. 41 is a schematic illustration of a tube with a precurved shape,according to an embodiment.

FIG. 42 is a schematic illustration of a shape-retaining element,according to an embodiment.

FIG. 43 is a schematic illustration of a tube with a beveled intake end,according to an embodiment.

FIG. 44A is a schematic illustration of an impermeable casing with aprecurved shape including a channel and an opening to remove urinecollected from a user, according to an embodiment.

FIG. 44B is a schematic illustration of a cross-sectional view of thecasing in FIG. 44A, taken along the line 44B-44B.

FIG. 44C is a schematic illustration of a cross-sectional view of thecasing in FIG. 44A, taken along the line 44C-44C.

FIG. 44D is a schematic illustration of a cross-sectional bottom view ofthe impermeable backing in the casing shown in FIG. 44A showing anopening from a reservoir.

FIG. 45 is a schematic illustration of a casing with a tube and anopening from the reservoir of an assembly, according to an embodiment.

FIGS. 46 and 47 are a schematic side view and exploded view of anassembly with a casing and a porous support material, according to anembodiment.

FIG. 48 is an illustration of a top view of a sheet of material used asthe permeable support of the embodiment of FIGS. 46 and 47.

FIG. 49A is a schematic illustration of a cross-sectional view of anassembly, according to an embodiment.

FIG. 49B is a schematic illustration of a cross-sectional view of animpermeable casing of the assembly of FIG. 49A.

FIG. 49C is a schematic illustration of a cross-sectional view of theimpermeable casing of FIG. 49B taken along line 49C-49C.

FIG. 50A is a schematic illustration of an assembly with more than oneoutlet tube, according to one embodiment.

FIG. 50B is a cross-sectional view of the assembly of FIG. 50A, takenalong the line 50B-50B.

FIG. 51 is a shallow angled perspective view of the assembly of FIG.50A.

DETAILED DESCRIPTION

A system is disclosed that is suitable for collecting and transportingurine away from the body of a person or animal. The disclosed systemincludes an assembly that may include a fluid impermeable casing havinga fluid reservoir at a first end, a fluid outlet at a second end, and alongitudinally extending fluid impermeable layer coupled to the fluidreservoir and the fluid outlet and defining a longitudinally elongatedopening between the fluid reservoir and the fluid outlet. The assemblycan further include a fluid permeable support disposed within the casingwith a portion extending across the elongated opening, and a fluidpermeable membrane disposed on the support and covering at least theportion of the support that extends across the elongated opening, sothat the membrane is supported on the support and disposed across theelongated opening. The assembly can further include a tube having afirst end disposed in the reservoir and extending behind at least theportion of the support and the portion of the membrane disposed acrossthe elongated opening and extending through the fluid outlet to asecond, fluid discharge end. The assembly can be configured to bedisposed with the opening adjacent to a urethral opening of a user, toreceive urine discharged from the urethral opening through the openingof the fluid impermeable layer, the membrane, the support, and into thereservoir, and to have the received urine withdrawn from the reservoirvia the tube and out of the fluid discharge end of the tube.

In some embodiments, a method includes disposing in operativerelationship with the urethral opening of a female user, a urinecollecting apparatus. The urine collecting apparatus can include a fluidimpermeable casing having a fluid reservoir at a first end, a fluidoutlet at a second end, and a longitudinally extending fluid impermeablelayer coupled to the fluid reservoir and the fluid outlet and defining alongitudinally elongated opening between the fluid reservoir and thefluid outlet. The urine collecting apparatus can also include a fluidpermeable support disposed within the casing with a portion extendingacross the elongated opening, a fluid permeable membrane disposed on thesupport and covering at least the portion of the support that extendsacross the elongated opening, so that the membrane is supported on thesupport and disposed across the elongated opening, and a tube having afirst end disposed in the reservoir and extending behind at least theportion of the support and the portion of the membrane disposed acrossthe elongated opening and extending through the fluid outlet to asecond, fluid discharge end. The operative relationship can include theopening being adjacent to the urethral opening. The method can furtherinclude allowing urine discharged from the urethral opening to bereceived through the opening of the fluid impermeable layer, themembrane, the support, and into the reservoir; and allowing the receivedurine to be withdrawn from the reservoir via the tube and out of thefluid discharge end of the tube.

In some embodiments, an apparatus includes a fluid permeable supportdisposed between a fluid permeable membrane and a fluid reservoir, and afluid outlet. The apparatus can be configured to be disposed with aportion of the fluid permeable membrane adjacent to a urethral openingof a user, to receive urine discharged from the urethral opening throughthe fluid permeable membrane, the fluid permeable support, and into thereservoir, and to have the received urine withdrawn from the reservoirvia the outlet.

As used in this specification, the singular forms “a,” “an” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “a member” is intended to mean a singlemember or a combination of members, “a material” is intended to mean oneor more materials, or a combination thereof.

The embodiments described herein can be formed or constructed of one ormore biocompatible materials. Examples of suitable biocompatiblematerials include metals, ceramics, or polymers. Examples of suitablemetals include pharmaceutical grade stainless steel, gold, titanium,nickel, iron, platinum, tin, chromium, copper, and/or alloys thereof.Examples of polymers include nylons, polyesters, polycarbonates,polyacrylates, polymers of ethylene-vinyl acetates and other acylsubstituted cellulose acetates, non-degradable polyurethanes,polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulphonate polyolefins, polyethylene oxide,polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), and/orblends and copolymers thereof.

FIG. 1 is a schematic block diagram of a system 100. The system 100includes an assembly 102. The assembly 102 includes a reservoir 110, apermeable support 140, and a permeable membrane 130. The assembly 102also includes an outlet 120 in fluidic communication with the reservoir110. The assembly 102 can be arranged such that a fluid can flow throughthe permeable membrane 130, through the permeable support 140, into thereservoir 110, and out of the outlet 120. In some implementations, theassembly 102 can also include an impermeable layer 150 for directingfluid toward the reservoir 110 and reducing and/or preventing fluid fromexiting the assembly 102 except via the outlet 120. In someimplementations, the system 100 can include a discharge line 122. Thedischarge line 122 can be fluidically coupled to an external receptacle160. The external receptacle 160 can be in fluidic communication with avacuum source 170 via a vacuum line 124. The discharge line 122 and thevacuum line 124 can both include flexible tubing, such as, for example,flexible plastic tubing.

The permeable membrane 130 can be formed of a material that haspermeable properties with respect to liquids such as urine. Thepermeable properties can be wicking, capillary action, diffusion, orother similar properties or processes, and are referred to herein as“permeable” and/or “wicking.” The permeable membrane 130 can have a highabsorptive rate and a high permeation rate such that urine can berapidly absorbed by the permeable membrane 130 and/or transportedthrough the permeable membrane 130. In some implementations, thepermeable membrane 130 can be a ribbed knit fabric. In someimplementations, the permeable membrane 130 can include and/or have themoisture-wicking characteristic of gauze, felt, terrycloth, thick tissuepaper, and/or a paper towel. In some implementations, the permeablemembrane 130 can be soft and/or minimally abrasive such that thepermeable membrane 130 does not irritate the skin of the user. Thepermeable membrane 130 can be configured to wick fluid away from theurethral opening and/or the skin of the user such that the dampness ofthe skin of the user is lessened and infections are prevented.Additionally, the wicking properties of the permeable membrane 130 canhelp prevent urine from leaking or flowing beyond the assembly onto, forexample, a bed. In some implementations, the permeable membrane 130 canbe formed of fine denier polyester fibers coated with a thermoplasticwater-based binder system. The tensile with the Webb direction can be,for example, about 45 lbs/inch² measured using an Instron test method.The weight per permeable membrane can be, for example, about 12 gramsmeasured using the Mettle Gram Scale. The thickness per ten permeablemembrane can be, for example, about 2.5″, measured using theGustin-Bacon/Measure-Matic.

The permeable support 140 can be positioned relative to the permeablemembrane 130 such that the permeable support 140 maintains the permeablemembrane 130 in a particular shape and allows for fluid, such as, forexample, urine, to flow through the permeable membrane 130, through thepermeable support 140, and into the reservoir 110. In someimplementations, the permeable support 140 can be configured to maintainthe permeable membrane 130 against or near a urethral opening of a user.For example, the permeable support 140 can include a portion having acurved shape in contact with the permeable membrane 130 such that thepermeable membrane 130 is also curved, thus creating a comfortable andsecure interface for engagement with a user's urethral opening and/orthe area of the body near the urethral opening. In some implementations,the permeable support 140 can be made of a rigid plastic. In someimplementations, the permeable support 140 can have any suitable shapeand be formed of any suitable material. For example, the permeablesupport 140 can be flexible. Additionally, the permeable support 140 canbe formed of aluminum, a composite of plastic and aluminum, some othermetal and/or a composite of plastic and another metal. In someimplementations, the permeable support 140 can be formed of a naturalmaterial, such as, for example, plant fibers (e.g., Greener Cleanmanufactured by 3M®). The natural material can include openings thatallow fluid to flow through the natural material. In some embodiments,the permeable support 140 can be cylindrical and can define a lumen. Insome embodiments, the permeable support 140 can be formed of perforatedcoated paper, such as tubular waxed paper.

The permeable support 140 can define one or more openings (e.g., anarray of openings) to allow for fluid flow from the permeable membrane130 to the reservoir 110. In some implementations, the permeable support140 can be formed as a tube, a cylinder, or a curved cylinder with oneor more openings. In some implementations, the permeable support 140 caninclude membrane supports (e.g., struts) extending across an openingsuch that the opening is divided into an array of distinct slot-shapedopenings. The membrane supports can be used to support the permeablemembrane 130. For example, the membrane supports can maintain the shapeof the permeable membrane 130 against or near a user's urethral openingsuch that urine flowing from the urethral opening contacts and travelsthrough the permeable membrane 130. In some implementations, thepermeable support 140 can define several openings having a variety ofshapes, such as a plurality of round openings. In some implementations,the permeable support 140 can be formed as a cylinder of spun plastic(e.g., non-woven permeable nylon and polyester webbing) such that thepermeable support 140 can have many openings. For example, a rectangularportion of spun plastic can be folded or rolled into a cylinder shapefor use in the assembly 102. In some implementations, the permeablesupport 140 can be formed of a porous material. For example, thepermeable support 140 can be a porous glass tubular container definingfrits. In other implementations, the permeable support 140 can define anopening in a sidewall of the permeable support 140 and the sidewall canbe covered by a mesh screen defining many smaller openings.

The reservoir 110 can be any suitable shape and/or size capable ofcollecting fluid transported through the permeable support 140. In someimplementations, the reservoir 110 can be sized such that the reservoiris capable of collecting and temporarily holding a large or small amountof urine until the urine can be removed from the reservoir via theoutlet 120. For example, the reservoir 110 can be sized such that thereservoir 110 is configured to hold a small amount of urine as may bereleased due to incontinence. In some implementations, the reservoir 110can be sized such that the reservoir 110 is configured to hold a largeamount of urine as may be released during voiding of a full bladder. Insome implementations, the reservoir 110 can be sized such that thereservoir is configured to collect and hold a small or large amount ofurine while the urine is simultaneously removed via, for example,gravity and/or a pump, such as the vacuum source 170. Said another way,the reservoir 110 can function as a sump and be sized such that thereservoir 110 can form a portion of a passageway for urine from thepermeable membrane 130, through the permeable support 140, through thereservoir 110, and out of the outlet 120. In a condition where the flowrate of urine into the assembly 102 via the permeable membrane 130 isgreater than the flow rate of urine through the discharge line 122, atemporary backup of urine may occur in the reservoir 110. Thus, thereservoir 110 can be sized to contain a volume of fluid that maytemporarily accumulate due to the difference in flow rates into and outof the assembly 102.

Although the outlet 120 is shown as extending from the side of thereservoir 110, in some implementations, the outlet 120 can extend fromthe bottom of the reservoir 110. Positioning the outlet 120 lower in thereservoir 110 such that less or no urine can pool at the bottom of thereservoir 110 can allow for urine to be removed from the reservoir 110more quickly and/or completely. In other implementations, the outlet 120can be positioned within the reservoir such that at least a portion oftubing associated with the outlet 120 extends from the top of thereservoir 110. For example, a portion of tubing associated with theoutlet 120 can extend from the top of the reservoir 110 through at leasta portion of the permeable support 140 (e.g., a central channel) and,optionally, through at least a portion of the permeable membrane 130. Insuch an implementation, the outlet 120 can be positioned a distance fromthe reservoir 110 such that fluid can flow from the reservoir, throughthe tubing associated with the outlet 120, and from the outlet 120. Insuch implementations, positioning the reservoir end of the tubingassociated with the outlet 120 towards the bottom of the reservoir 110such that less or no urine can pool at the bottom of the reservoir 110can allow for urine to be removed from the reservoir 110 more quicklyand/or completely. In some implementations, the tubing associated withthe outlet 120 can be precurved at least in the portion extendingthrough the permeable support 140.

In some implementations, the reservoir 110 and the permeable support 140can be formed as separate components and coupled together duringassembly. In some implementations, the permeable support 140 and thereservoir 110 can be formed as a cylindrical integral, unitary structurethat is sealed at one end by a closed end of the reservoir 110 and atthe other end by a closed end of the permeable support 140.

The external receptacle 160, via the discharge line 122, can collectfluid exiting the reservoir 110 through the outlet 120. The externalreceptacle 160 can be a sealed container. In some implementations, theexternal receptacle 160 can be disposable. In some implementations, theexternal receptacle 160 can be configured to be sterilized and reused.

In some implementations, gravity can cause fluid within the reservoir110 to follow a flow path (i.e., the fluid flow path including theoutlet 120 and the discharge line 122) from the reservoir 110 to theexternal receptacle 160. In some implementations, the vacuum source 170can assist and/or provide the pressure differential needed to draw fluidvoided from the urethral opening of a user into the permeable support140, into the reservoir 110, and from the reservoir 110 into theexternal receptacle 160. The vacuum source 170 can be fluidicallycoupled to the external receptacle 160 via a vacuum line 124 such thatgaseous fluid is drawn from the external receptacle 160 via the vacuumline 124. As a result of the decrease in pressure within the externalreceptacle 160 caused by the drawing of gaseous fluid out of theexternal receptacle 160, liquid and/or gaseous fluid can be drawn fromthe reservoir 110, through the outlet 120, through the discharge line122, and into the external receptacle 160. In some implementations, thevacuum source 170 can apply sufficient suction to capture all orsubstantially all of the urine voided by a user in a variety ofpositions (e.g., when a female user is lying on her side).

The vacuum source 170 can have a sufficiently high vacuum strength andair volume transport rate such that rapid air and liquid aspiration ismaintained over a portion of or the entire permeable membrane 130. Insome implementations, the one or more openings of the permeable support140 are distributed over an area that is slightly larger than the areaof the permeable membrane 130 that is configured to be wetted by urineflow in operation. Thus, the partial vacuum created by the vacuum source170 in combination with the one or more openings of the permeablesupport 140 and the permeable membrane 130 can draw the urine contactingthe permeable membrane 130 into the assembly 102. In someimplementations, however, the one or more openings of the permeablesupport 140 should not be distributed over too large of an area of thepermeable support 140 because the partial vacuum strength may bereduced, thereby reducing the urine collection rate and the efficiencyof the system 100.

In some implementations, the vacuum source 170 can be a pump that isreadily available, inexpensive, relatively quiet, and/or configured torun continuously. For example, the vacuum source 170 can be an aquariumaerator pump. The vacuum line 124 can be attached to the intake port ofthe aquarium aerator pump (rather than the exhaust port of the aerator)such that gaseous fluid is drawn into the aquarium aerator pump from theexternal receptacle 160 via the vacuum line 124. In someimplementations, the necessary static vacuum of the system 100 is about3-10 feet of water (10%-30% of one atmosphere; 80-250 mm Hg) with afree-flow rate of about 10-100 cubic centimeters per second. In someimplementations, the necessary static vacuum of the system 100 is higheror lower depending on the size of the user and the expected rate ofurine flow from the user and/or through the system 100. In someimplementations, the discharge line 122 can be about 0.25″ in diameterand the vacuum source 170 can be configured to cause about 500 cubiccentimeters of urine to flow through the discharge line 122 to theexternal receptacle 160 over the duration of a typical urination eventfor a user, which may typically range from 10 to 20 seconds but may beshorter or longer, e.g., 5 to 90 seconds. In some implementations, thevacuum source 170 can include a wall-mounted vacuum system, such as isfound in hospitals. In some implementations, a wall-mounted vacuumsystem can be configured to apply a vacuum of, for example, about 20 mmHg to about 40 mm Hg. In some implementations, the vacuum source 170 canbe powered by electrical AC or DC power. For example, in mobileapplications when the user is away from an AC power source, such as whenthe user is using the system 100 during transportation via a wheel chairor motor vehicle, the vacuum source 170 can be powered by DC power.

The impermeable layer 150 can be impermeable to fluid, such as, forexample, urine. In some implementations, the impermeable layer 150 canhave a fluid transportation function and can assist in directing fluidtowards the reservoir 110 and/or through the outlet 120 of the reservoir110. In some implementations, the impermeable layer 150 can be formed asan integral, unitary structure. In other implementations, theimpermeable layer 150 can be a multi-piece structure. The impermeablelayer 150 can be a pre-molded (e.g., injection or blow molded)component. Alternatively, the impermeable layer 150 can be formed of amaterial, such as elongate strips of an adhesive tape, wrapped around atleast a portion of the reservoir, a portion of the permeable support140, and/or a portion of the permeable membrane 130. In someimplementations, the impermeable layer 150 can be formed of cardboard,pressed paper, and/or coated paper.

In some implementations, as shown in FIG. 1, the assembly 102 canoptionally include a shape-defining or shape-retaining element 151. Theshape-retaining element 151 can be attached to the impermeable layer 150and can cause at least a portion of the assembly 102 to assume ormaintain a curved shape. In some implementations, the shape-retainingelement 151 can be disposed between the impermeable layer 150 and thepermeable support 140 and/or the permeable membrane 130. In someimplementations, the shape-retaining element 151 can be attached to anouter surface of the impermeable layer 150 or can be imbedded in theimpermeable layer 150. In some embodiments the tubing associated withthe outlet 120 can constitute the shape-retaining element 151, i.e. thetubing can be relatively rigid and having a curved shape that definesthe desired curved shape for at least a portion of the assembly 102.

In some implementations, the permeable support 140 can optionallyinclude a spine 148. The spine 148 can divide an inner volume of thepermeable support 140 into two or more longitudinal chambers and canstrengthen the permeable support 140 such that the permeable support 140maintains an intended shape. The two chambers can be aligned with aninlet of the permeable support 140 (i.e., the one or more openings inthe permeable support 140) such that fluid can flow through the inlet,through at least one of the two chambers, and into the reservoir 110.Although only one spine 148 is described, in some implementations, thepermeable support 140 can include additional spines such that thepermeable support 140 is divided into additional chambers.

In some implementations, the permeable support 140 can optionallyinclude a tunnel 146. The tunnel 146 can be coupled to the outlet 120 ofthe assembly 102 in a configuration in which the outlet 120 ispositioned on the top of the assembly 102. In some implementations, anexternal tube can be inserted through the tunnel 146 into contact withfluid in the reservoir 110 such that the fluid in the reservoir 110 canbe removed from the assembly 102 via the external tube (e.g., using avacuum source such as vacuum source 170). In some implementations, alength of tubing, such as the discharge line 122, can be fluidicallycoupled to an end of the tunnel 146 such that fluid can be drawn up thetunnel 146 from the reservoir 110 and out of the assembly 102.

In some implementations, the impermeable layer 150 can include anextension portion 156. The extension portion 156 can extend away fromthe permeable membrane 130 and/or the permeable support 140 such thatthe extension portion 156 can be gripped by a user or caregiver withoutcontacting the permeable membrane 130. Thus, the extension portion 156can be used to remove the permeable membrane 130 and the impermeablelayer 150 from the permeable support 140. In some implementations, theextension portion 156 can be shaped as an elongated tab that extendsalong the length of the assembly 102 on one or more sides of theassembly 102. In some implementations, the extension portion 156 can beconfigured to prevent urine from traveling beyond the border between thepermeable membrane 130 and the impermeable layer 150. For example, theextension portion 156 can be shaped and disposed relative to thepermeable membrane 130 such that in a condition where the rate of urineflowing from the urethral opening exceeds the rate the permeablemembrane 130 or a portion of the permeable membrane 130 can wick fluidand/or the rate that fluid can travel through the permeable membrane 130and permeable support 140, the extension portion 156 can prevent urinefrom flowing onto an outer surface of the impermeable layer 150 beyondthe extension portion 156 and can redirect urine along the permeablemembrane 130 such that the urine is directed through the permeablemembrane 130.

In some implementations, the impermeable layer 150 can include astabilizer 154. The stabilizer 154 can be configured to stabilize theassembly 102 relative to a user's body. For example, in some situationsof use, such as for incontinence, for disability that limits or impairsmobility, for restricted travel conditions (e.g., conditions experiencedby pilots, drivers, and/or workers in hazardous areas), for monitoringpurposes, or for clinical testing, it may aid the engagement between thepermeable membrane 130 and the user's urethral opening and/or the areasurrounding the urethral opening to include the stabilizer 154. Thestabilizer 154 can be coupled to or integrally formed with theimpermeable layer 150. In some implementations, a first end of thestabilizer 154 is coupled to the impermeable layer 150 and a second endof the stabilizer 154 is coupled to a user's body (e.g., via adhesive ortape) or an apparatus occupied by the user (e.g., a bed or wheelchair)to stabilize the position of the assembly 102 relative to a user'surethral opening and/or the area surrounding the urethral opening. Thestabilizer 154 can be a thin, pliable strip of material. For example, insome implementations the stabilizer 154 can include tape, gauze, cotton,cloth, or plastic. The stabilizer 154 can be any suitable length and/orwidth. In some implementations, the stabilizer 154 can be as thin as asingle thread.

In some implementations, the impermeable layer 150 can define one ormore vacuum relief openings 158. Thus, in the event that a user's bodyenvelopes the assembly 102, the one or more vacuum relief openings 158can prevent suction from increasing against the skin of the user, whichmay be uncomfortable or painful. Said another way, the one or morevacuum relief openings 158 can be located between two ends of theimpermeable layer 150 such that at least one additional airflow pathexists in the assembly 102. The one or more vacuum relief openings 158can be disposed at any suitable location on the impermeable layer 150.For example, in some implementations, the one or more vacuum reliefopenings 158 can be disposed near the outlet 120 of the apparatus 102.In some implementations, the one or more vacuum relief openings 158 canbe disposed in a location that reduces the likelihood that the skin ofthe labia or the thigh of the user inadvertently covers the hole, suchas a location near the outlet 120.

In some implementations, urine collected by any of the systems and/orassemblies described herein can be sampled for analysis using urinestrips. Urine test strips can be used to test a variety of healthmeasures. Urine test strips can be configured to change color inresponse to being wetted with urine to indicate a particular measurement(i.e., the colors can correspond to known measurement scales). In someimplementations, a urine test strip 162 can be inserted into thedischarge line 122 such that urine flowing from the outlet 120 to theexternal receptacle 160 contacts the urine test strip 162. The dischargeline 122 can be transparent such that data on the urine test strip 162can be read through a wall of the discharge line 122. In someimplementations, the urine test strip 162 can be disposed within theexternal receptacle 160 such that urine flowing into the externalreceptacle 160 contacts the urine test strip 162. The externalreceptacle 160 can be at least partially transparent such that the urinetest strip 162 can be read through a wall of the external receptacle160.

As an example, FIG. 14 is a schematic illustration of a portion oftubing line 1022 and a urine test strip 1062 affixed to the inside ofthe portion of tubing line 1022. The portion of tubing line 1022 can beincluded in or form the entire discharge line (e.g., discharge line 122)from an outlet of an assembly (e.g., outlet 120) to an externalreceptacle (e.g., external receptacle 160). The urine test strip 1062can be secured within the tubing line 1022 by friction or by using anysuitable adhesive. In some implementations, the tubing line 1022 can bea short tube segment (e.g., less than six inches) that is configured toform a portion of or all of a discharge line (e.g., discharge line 122).For example, the tubing line 1022 can have a connector on each end (notshown) capable of connection with and removal from a line of tubing(e.g., discharge line 122), an outlet (e.g., outlet 120), and/or theexternal receptacle (e.g., external receptacle 160). After urine haspassed through the tubing line 1022 and the data has been read from theurine test strip 1062, the tubing line 1022 and the urine test strip1062 can be disposed of.

In some implementations, a camera, such as a camera built into aportable communication device (e.g., a smartphone, an iPhone, or thelike) can be used to read the data on the urine test strip 162. Thecamera can capture an image of the test strip and the image can beprocessed using, for example, a smartphone application. The data readfrom the urine test strip can be sent to a clinician for analysis and/orsent to a cloud-based address for physician access.

In some implementations, the system 100 can include a scale 164. Forexample, the scale 164 can be disposed underneath the externalreceptacle 160 such that the scale is configured to measure the weightof fluid (e.g., urine) in the external receptacle 160. The dataindicating the weight of the fluid that has been delivered to theexternal receptacle 160 via the discharge line 122 can be measured atdifferent time intervals and processed to determine how much urine, forexample, has been voided by a user of the system 100.

Although described as being intended for use by an adult female, in someimplementations the system 100 can be used in adult, pediatric, male,female, and veterinary applications for animals of different species andsizes. In female applications, the assembly 102 can be placed betweenthe legs or labia of the user and held snugly against the externalurethra by the pressure of friction from the user's body, by thepressure of the legs or by such means as an undergarment, elasticstrips, and/or adhesive tape. In male applications, the assembly 102 canbe secured around the penis.

FIG. 2 is a perspective view of an assembly 202 with a portion of theassembly 202 shown in cut away. The assembly 202 includes a permeablesupport 240 and a reservoir 210. As shown in FIG. 2, the permeablesupport 240 and the reservoir 210 can be formed as a unitary structure.For example, the permeable support 240 and the reservoir 210 incombination can form a cylindrical container with closed ends. Thecylindrical container with closed ends can define an interior volume.The permeable support 240 can define an inlet 242 in a sidewall of thepermeable support 240 such that fluid can flow through the inlet 242into the interior volume. The reservoir 210 can define an opening 211and can be coupled to an outlet 220 such that the outlet 220 is in fluidcommunication with the opening 211. Thus, fluid can flow from theinterior volume, through the opening 211, and through the outlet 220.

The permeable support 240 can include one or more membrane supports 244.The membrane supports 244 can be formed as struts that extend across theinlet 242. Said another way, the membrane supports 244 can divide theinlet 242 into an array of distinct slot-shaped openings (or an array ofslot-shaped openings can define the membrane supports). The membranesupports 244 can be used to support a permeable membrane (e.g.,permeable membrane 230 shown in FIG. 3). For example, the membranesupports 244 can maintain the shape of the permeable membrane 230against a user's urethral opening and/or the area surrounding a user'surethral opening such that urine flowing from the urethral openingcontacts and travels through the permeable membrane 230. The membranesupports 244 can be formed in any suitable shape and/or thickness.

The permeable support 240 and the reservoir 210 can be formed of anysuitable material. In some implementations, the permeable support 140can be flexible. In some implementations, the permeable support 140 canbe rigid. In some implementations, the permeable support 240 can be madeof plastic, aluminum, a composite of plastic and aluminum, some othermetal and/or a composite of plastic and another metal. Additionally,although not shown in FIG. 2, in some implementations the permeablesupport 240 can be curved.

The assembly 202 can include a permeable membrane 230. FIG. 3 is aperspective view of the assembly 202 with the permeable membrane 230disposed on an outer surface of the permeable support 240. In someimplementations, the permeable membrane 230 can also be disposed on aportion of or on the entire outer surface of the reservoir 210. Thepermeable membrane 230 can be at least partially supported by themembrane supports 244 (shown in FIG. 2) such that the membrane supports244 maintain the permeable membrane 230 against or near a urethralopening of a user.

The permeable membrane 230 can be formed of a material that is urinepermeable and has wicking properties. The permeable membrane 230 canhave a high absorptive rate and a high permeation rate such that urinecan be rapidly wicked by the permeable membrane 230 and/or transportedthrough the permeable membrane 230. In some implementations, thepermeable membrane 230 can be a ribbed knit fabric. In someimplementations, the permeable membrane 230 can include and/or have themoisture-wicking characteristic of gauze, felt, terrycloth, thick tissuepaper, and/or a paper towel. In some implementations, the permeablemembrane 230 can be soft and/or minimally abrasive such that thepermeable membrane 230 does not irritate the skin of the user. Thepermeable membrane 230 can be configured to wick fluid away from theurethral opening and/or the skin of the user such that the dampness ofthe skin of the user is lessened and infections are prevented.Additionally, the wicking properties of the permeable membrane 230 canhelp prevent urine from leaking or flowing beyond the assembly onto, forexample, a bed. In some implementations, the permeable membrane 130 canbe formed of fine denier polyester fibers coated with a thermoplasticwater-based binder system. The tensile with the Webb direction can be,for example, about 45 lbs/inch² measured using an Instron test method.The weight per permeable membrane can be, for example, about 12 gramsmeasured using the Mettle Gram Scale. The thickness per ten permeablemembrane can be, for example, about 2.5″, measured using theGustin-Bacon/Measure-Matic.

In some implementations, the permeable membrane 230 can be formed as asock or sleeve that can be slid over the permeable support 240. In someimplementations, the permeable membrane 230 can be formed as a sheetthat can be wrapped partially or completely around the permeable support240. The permeable membrane 230 can be secured in place with one or moresecuring elements 252. In some implementations, the securing elements252 can be impermeable and form a portion of or all of an impermeablelayer (similar to impermeable layer 150 with reference to assembly 100of FIG. 1). In some implementations, the securing elements 252 caninclude elastic bands (e.g., rubber bands), water-resistant adhesivetape, spring clips, hook and loop fasteners, zippers, snaps, and/or anyother suitable securing element. In other implementations, the permeablemembrane 230 can be secured in place via friction between the permeablemembrane 230 and the permeable support 240.

FIG. 4 is a schematic illustration the assembly 202 as part of a system200. The system 200 includes an external receptacle 260 and a vacuumsource 270. The external receptacle 260 can be the same or similar instructure and/or function as the external receptacle 160 described abovewith reference to the system 100. The vacuum source 270 can be the sameor similar in structure and/or function as the vacuum source 170described above with reference to the system 100. The assembly 202 canbe fluidically coupled to the external receptacle 260 via a dischargeline 122. The external receptacle 260 can be fluidically coupled to thevacuum source 270 via a vacuum line 224.

In use, the system 200 can be positioned such that the assembly 202 isabutting and/or near the urethral opening of the user. In particular,the assembly 202 can be positioned such that the inlet 242 and membranesupports 244 are facing the urethral opening such that urine exiting theurethral opening can travel through the permeable membrane 230, throughthe inlet 242, through the interior volume defined by the permeablesupport 240 and the reservoir 210, and through the outlet 220. Theassembly 202 can be arranged relative to the urethral opening of theuser such that gravity causes or assists urine entering the permeablesupport 240 in traveling to the reservoir 210. Similarly as describedabove with reference to system 100, the vacuum source 270 can assistand/or provide the pressure differential needed to draw fluid voidedfrom the urethral opening into the inner volume of the assembly 202, andthen from the reservoir 210 into the external receptacle 260. The vacuumsource 270 can have a sufficiently high vacuum strength and air volumetransport rate such that rapid air and liquid aspiration is maintainedover a portion of or the entire permeable membrane 230. Additionally,the inlet 242 can be sized and shaped such that the inlet 242 is largerthan the area of the permeable membrane 230 that is configured to bewetted by urine flow in operation. Thus, the partial vacuum created bythe vacuum source 270 in combination with the inlet 242 and thepermeable membrane 230 can draw the urine contacting the permeablemembrane 230 into the assembly 202. In some implementations, however,the inlet 242 should not be distributed over too large of an area of thepermeable support 240 because the partial vacuum strength may bereduced, thereby reducing the urine collection rate and the efficiencyof the system 200. The vacuum source 270 can be fluidically coupled tothe external receptacle 260 via a vacuum line 224 such that gaseousfluid is drawn from the external receptacle 260 via the vacuum line 224.As a result of the decrease in pressure within the external receptacle260 caused by the drawing of gaseous fluid out of the externalreceptacle 260, liquid and/or gaseous fluid can be drawn from thereservoir 210, through the outlet 220, through the discharge line 222,and into the external receptacle 260.

FIG. 5 is a schematic illustration of a system 300. The system 300includes an assembly 302. The assembly 302 can be the same or similar instructure and/or function to the assembly 102 or the assembly 202described above. The system 300 can include an external receptacle 360and a vacuum source 370. The external receptacle 360 can be the same orsimilar in structure and/or function as the external receptacle 160and/or the external receptacle 260 described above. The vacuum source370 can be the same or similar in structure and/or function as thevacuum source 170 and/or the vacuum source 270 described above.

As shown in FIG. 5, the system 300 can include a chassis 372. The vacuumsource 370 can be mounted on the chassis 372. A discharge pipe 374 and avacuum intake pipe 376 can be mounted on or disposed within the chassis372. The discharge pipe 374 can be fluidically coupled to the assembly302 via a discharge line 322. The vacuum intake pipe 376 can befluidically coupled to a vacuum line extending away from the chassis372. The chassis 372 can be mounted on and/or coupled to the externalreceptacle 360. For example, in some implementations, the chassis caninclude helical threads configured to engage with helical threads on theexternal receptacle 360 such that the chassis 372 can engage with theexternal receptacle 360.

In use, the system 300 can be positioned such that the assembly 302 isabutting and/or near the urethral opening of the user. In particular,the assembly 302 can be positioned such that one or more openings in thepermeable support (not shown) of the assembly 302 face the urethralopening such that urine exiting the urethral opening can travel througha permeable membrane of the permeable support, through the one or moreopenings, through an interior volume defined by the permeable supportand a reservoir of the assembly 302, and through an outlet of theassembly 302 into the discharge line 322. The assembly 302 can bearranged relative to the urethral opening of the user such that gravitycauses urine entering the permeable support to travel to the reservoir.Similarly as described above with reference to system 100 and/or system200, the vacuum source 370 can assist and/or provide the pressuredifferential needed to draw fluid (e.g., urine) voided from the urethralopening into the inner volume of the assembly 302, and then from thereservoir, through the discharge line 322, and into the externalreceptacle 360. The vacuum source 370 can have a sufficiently highvacuum strength and air volume transport rate such that rapid air andliquid aspiration is maintained over a portion of or the entirepermeable membrane. The vacuum source 370 can be fluidically coupled tothe external receptacle 360 via the vacuum intake pipe 376 such thatgaseous fluid is drawn from the external receptacle 360 via the vacuumintake pipe 376. The gaseous fluid can then be released from the system300 via a vacuum line 324. As a result of the decrease in pressurewithin the external receptacle 360 caused by the drawing of gaseousfluid out of the external receptacle 360, liquid and/or gaseous fluidcan be drawn from the assembly 302, through the discharge line 322, andinto the external receptacle 360.

In some implementations, rather than the permeable support and thereservoir being combined as a unitary or integral structure and shapedas a cylinder of constant diameter (e.g., permeable support 240 andreservoir 210 of FIG. 2), a permeable support and a reservoir can beformed as a unitary structure having any suitable shape, as shown inFIGS. 6A-6C, which are schematic illustrations of various assemblyshapes. For example, as shown in FIG. 6A, an assembly 402 includes apermeable support 440 and a reservoir 410. The permeable support 440 andthe reservoir 410 are formed as a unitary structure having a curvedshape. The permeable support 440 defines an inlet 442 and includes anumber of membrane supports 444. The membrane supports 444 extend acrossthe inlet 442. In other words, the membrane supports 444 divide theinlet 442 into a number of discrete inlet portions.

As shown in FIG. 6B, an assembly 502 includes a permeable support 540and a reservoir 510. The permeable support 540 and the reservoir 510 areformed as a unitary structure having a straight shape with a largerdiameter end portion. Thus, the reservoir 510 can have a larger diameterthan the permeable support 540. The permeable support 540 defines aninlet 542 and includes a number of membrane supports 544. The membranesupports 544 extend across the inlet 542. In other words, the membranesupports 544 divide the inlet 542 into a number of discrete inletportions.

As shown in FIG. 6C, an assembly 602 includes a permeable support 640and a reservoir 610. The permeable support 640 and the reservoir 610 areformed as a unitary structure having concave sides. The permeablesupport 640 defines an inlet 642 and includes a number of membranesupports 644. The membrane supports 644 extend across the inlet 642. Inother words, the membrane supports 644 divide the inlet 642 into anumber of discrete inlet portions.

FIG. 7 is a perspective view of an assembly 702 with a portion of theassembly 702 shown in cut away. The assembly 702 can be similar instructure and/or function to the assembly 202 described above withrespect to FIG. 2. For example, the assembly 702 includes a permeablesupport 740 and a reservoir 710. The permeable support 740 and thereservoir 710 are formed as an integral, unitary cylindrical containerwith closed ends. The cylindrical container with closed ends defines aninterior volume. The permeable support 740 can define an inlet 742 in asidewall of the permeable support 740 such that fluid can flow throughthe inlet 742 into the interior volume. The permeable support 740 caninclude one or more membrane supports 744. The membrane supports 744 canbe the same or similar in structure and function to the membranesupports 244 described above with reference to the permeable support240.

Rather than including an outlet extending from a side of the reservoir710, the outlet 720 of the reservoir 710 can be formed as an elongatedtube positioned within the reservoir 710 and extending through a portionof the reservoir 710, through the permeable support 740, and out a topend of the permeable support 740. Thus, fluid can flow (e.g., viasuction applied to the outlet 720) from the interior volume, through theoutlet 720, and out the top of the apparatus 702.

FIG. 8 is a perspective view of an assembly 802. The assembly 802 can besimilar in structure and/or function to the assembly 702 described abovewith respect to FIG. 7. For example, the assembly 802 includes apermeable support 840 and a reservoir 810. The permeable support 840 andthe reservoir 810 are formed as an integral, unitary curved cylindricalcontainer with closed ends. The cylindrical container with closed endsdefines an interior volume. The permeable support 840 can define anumber of inlets 842 in a sidewall 844 of the permeable support 840 suchthat fluid can flow through the number of inlets 842 into the interiorvolume. The sidewall 844 can support a permeable membrane, such aspermeable membrane 130 described above with reference to FIG. 1. Inparticular, the portions of the sidewall 844 defining and separating thenumber of inlets 842 can be the same or similar in structure andfunction to the membrane supports 244 described above with reference tothe permeable support 240. The assembly 802 can include an outlet 820similar to the outlet 720 describe above with reference to the assembly702. For example, the outlet 820 can be formed as an elongated tubepositioned within the reservoir 810 and extending through a portion ofthe reservoir 810, through the permeable support 840, and out a top endof the permeable support 840. Thus, fluid can flow (e.g., via suctionapplied to the outlet 820) from a urethral opening of a user, throughthe number of inlets 842 into the interior volume, to the reservoir 810,through the outlet 820, and out the top of the apparatus 802.

In some implementations, the assembly 802 can include a permeablemembrane (not shown) that includes a spray-on fabric, such as thespray-on fabric developed by Fabrican, Ltd. of London, England. Thespray-on fabric can be applied to the exterior of the permeable support840 and/or the reservoir 810. The spray-on fabric can include a liquidsuspension and can be applied via, for example, a spray gun or anaerosol can. The spray-on fabric can be formed by the cross-linking offibers which adhere to the exterior of the permeable support 840 suchthat the spray-on fabric forms an instant non-woven fabric when appliedto the exterior of the permeable support 840 and/or the reservoir 810.

In some implementations, the assembly 802 can include a permeablemembrane (not shown) similar in structure and function to any of thepermeable membranes described above (such as, for example, permeablemembrane 230) can be secured to the permeable support 840 and/or thereservoir 810. In some implementations, such as is shown in FIG. 9, theassembly 802 can include a permeable membrane 830 covering a portion orall of the permeable support 840 and/or the reservoir 810. The assembly802 can also include an impermeable layer 850. The permeable support 840and the impermeable layer 850 can form, in combination, a sheath-likestructure shaped and sized to be secured around at least a portion ofthe permeable support 840 and at least a portion of the reservoir 810.The impermeable layer 850 can be disposed relative to the permeablesupport 840, reservoir 810, and permeable membrane 830 such that thepermeable membrane 830 is configured for interfacing with a urethralopening and/or the area surrounding the urethral opening of a user andat least a portion of the number of inlets 842 are not covered by theimpermeable layer 850 such that urine from the urethral opening can flowthrough the permeable membrane 830, through the number of inlets 842,and into the inner volume of the assembly 802. The impermeable layer 850can be disposed such that the impermeable layer 850 can direct fluidtoward the reservoir 810 and reduce and/or prevent fluid from exitingthe assembly 802 except via the outlet 820.

The impermeable layer 850 can include one or more extension portions856. The one or more extension portions 856 can extend away from thepermeable membrane 830 and/or the permeable support 840 such that theone or more extension portions 856 can be gripped by a user or caregiverwithout contacting the permeable membrane 830. Thus, the one or moreextension portions 856 can be used to remove the permeable membrane 830and the impermeable layer 850 from the permeable support 840. In someimplementations, the one or more extension portions 856 can be shaped asan elongated tab that extends along the length of the assembly 802 onone or more sides of the assembly 802. Although not shown, in someimplementations, the permeable membrane 830 and/or the impermeable layer850 can include a handle (not shown). The handle can be shaped as a hoopand disposed on one end of the permeable membrane 830 and/or theimpermeable layer 850 to assist in positioning and removing thepermeable membrane 830 and/or the impermeable layer 850 from thepermeable support 840 and/or the reservoir 810.

In some implementations, the permeable membrane 830 can be formed as asheath with a closed end such that the permeable membrane 830 can bepulled over the permeable support 840 and the reservoir 810 like a sock.For example, the permeable membrane 830 can be heat sealed on one end.In such implementations, the impermeable layer 850 can be secured to aportion of the side and/or bottom of the permeable membrane 830. Inother implementations, the permeable membrane 830 can be formed as asheath with two open ends that can be pulled over the permeable support840 and the reservoir 810. In such implementations, the end of thepermeable membrane 830 near the reservoir 810 can be left uncovered, andthe impermeable layer 850 can be secured to a portion of the side and/orthe bottom of the permeable membrane 830. In some implementations, thepermeable membrane 830 can be a piece of material smaller than theexternal surface area of the permeable support 840. The permeablemembrane 830 can be heat sealed to the impermeable layer 850 such thatthe combination of the permeable membrane 830 and the impermeable layer850 form a sheath that can be secured to permeable support 840 and/orthe reservoir 810 via, for example, pulling over the permeable support840 and/or the reservoir 810 like a sock.

In some implementations, the assemblies described herein can includeinternal structures to direct fluid flow and/or provide structuralsupport. Additionally, in some implementations, the assemblies describedherein can include a first end cap and a second end cap. For example,the assemblies described herein can include the features shown anddescribed with respect to FIGS. 10-13. FIGS. 10 and 11 are a perspectiveview of a first end 943A and perspective view of a second end 943B,respectively, of a permeable support 940.

The permeable support 940 can include a tunnel 946 and a spine 948. Thetunnel can define a first chamber 941C. The spine 948 can divide aninner volume of the permeable support 940 into a second channel 941A anda third channel 941B. The first chamber 941C, the second channel 941A,and the third channel 941B can each run the length of the permeablesupport 940 and run parallel to one another. The spine 948 can be usedto strengthen the permeable support 940 such that the permeable support940 maintains an intended shape. The permeable support 940 can includeone or more openings (not shown) in a sidewall of the permeable support940. The one or more openings can be aligned with the second channel941A and the third channel 941B such that fluid can flow through the oneor more openings into the second channel 941A and the third channel941B. Although only one spine 948 is shown, in some implementations, thepermeable support 940 can include additional spines such that thepermeable support 940 is divided into additional channels. In someimplementations, the permeable support 940 can be formed without a spinesuch that the permeable support 940 only defines one channel in additionto the third channel 941C defined by the tunnel 946.

FIG. 12 is a perspective view of a first end cap 945 configured to becoupled to the first end 943A of the permeable support 940. The firstend cap 945 includes a first flange 949A, a second flange 949B, and athird flange 949C. The third flange 949C defines an opening 941D throughthe first end cap 945. The first flange 949A, the second flange 949B,and the third flange 949C can be shaped and sized such that the firstflange 949A, the second flange 949B, and the third flange 949C can becoupled within the third chamber 941B, the second chamber 941A, and thefirst chamber 941C, respectively. In some implementations, the firstflange 949A, the second flange 949B, and the third flange 949C can beshaped and sized such that the first flange 949A, the second flange949B, and the third flange 949C are configured to engage with the thirdchamber 941B, the second chamber 941A, and the first chamber 941C,respectively.

FIG. 13 is a perspective view of a second end cap 947 configured to becoupled to the second end 943B of the permeable support 940. The secondend cap 947 includes a first flange 949D, a second flange 949E, and athird flange 949F. The first flange 949D, the second flange 949E, andthe third flange 949F can be shaped and sized such that the first flange949D, the second flange 949E, and the third flange 949F can be coupledwithin the second chamber 941A, the first chamber 941C, and the secondchamber 941B, respectively. In some implementations, the second end cap947 can be shaped and sized such that the second end cap 947 cansealingly engage with the first chamber 941C, the second chamber 941A,and the third chamber 941B to prevent fluid leakage.

In an assembled configuration in which the first end cap 945 is coupledto the first end 943A of the permeable support 940 and the second endcap 947 is coupled to the second end 943B of the permeable support 940,the second end cap 947 and/or the permeable support 940 can define areservoir 910 for collection of fluid (e.g., urine). The third flange949C of the first end cap 945 can define an outlet for fluid collectedwithin the reservoir 910. In some implementations, an external tube canbe inserted through the first end cap 945 via the opening 941D definedby the third flange 949C and through the third channel 941C defined bythe tunnel 946 until an end of the external tube reaches fluid in thereservoir defined by the second end cap 947 and/or the permeable support940. The external tube can then be used to remove the fluid via suction.In some implementations, an external tube can be coupled to the firstend cap 945, rather than extended through the first end cap 945 and intothe permeable support 940. In such embodiments, suction can be appliedvia the external tube such that fluid (e.g., urine) in the reservoir 910can be transported via suction through the first channel 941C and out ofthe opening 941D. Although not shown, in some implementations, thesecond flange 949C of the first end cap 945 can extend from both sidesof the first end cap 945 such that the second flange 949C can form amale fitting for an external tube such that the external tube can becoupled to the second flange 949C.

In some implementations, the tunnel 946 can be formed such that a gapexists between the end of the tunnel 946 and the face of the second endcap 947 such that the tunnel 946 does not prevent fluid from flowingfrom the second channel 941A and/or the third channel 941B into thefirst channel 941C. In some implementations, the tunnel 946 is formedsuch that the gap between the tunnel 946 and the face of the second cap947 is small such that a large amount of fluid does not accumulate inthe reservoir 910 before reaching a height capable of being suctionedvia the tunnel 946.

In some implementations, the first end cap 945 and/or the second end cap947 can be rigid. The first end cap 945 and/or the second end cap 947can be, for example, injection molded and formed of plastic, such as ABSor nylon. In some implementations, the first end cap 945 and/or thesecond end cap 947 can be flexible. In some implementations, the firstend cap 945 and/or the second end cap 947 can be made of any suitablematerial using any suitable process.

In some implementations, the permeable support 940 can be formed of asoft material, such as, for example, polyurethane, polyethylene, orsynthetic rubber. The permeable support 940 can be formed via anextrusion process. In some implementations, the material used to formthe permeable support 940 can be coiled during the extrusion processsuch that the permeable support 940 has a curved shape to improve thefit of the permeable support 940 and/or a permeable membrane coupled tothe permeable support 940 with a user's urethral opening and/or theregion of a user's body surround the urethral opening. In someimplementations, the permeable support 940 can be formed via injectionmolding. In some implementations, the permeable support 940 can be rigidor flexible, and can be formed of any suitable material or combinationof materials.

In some implementations, a stabilizer can be used to maintain any of theassemblies described herein in a particular position relative to auser's body. For example, FIG. 15 is a perspective view of an assembly1102. The assembly 1102 can be the same or similar in structure andfunction to the assembly 202 described above with reference to FIG. 3.As shown in FIG. 15, a stabilizer 1154 is coupled to the assembly 1102such that the stabilizer 1154 can maintain the assembly 1102 in acertain position relative to a user's body. For example, in somesituations of use, such as incontinence, disability that limits orimpairs mobility, restricted travel conditions (e.g., conditionsexperienced by pilots, drivers, and/or workers in hazardous areas),monitoring purposes, or for clinical testing, the stabilizer 1154 canaid in maintaining the engagement between the assembly 1102 and theuser's urethral opening and/or the area surrounding the urethralopening. In some implementations, the stabilizer 1154 can be coupled toor integrally formed with an impermeable layer of the assembly 1102. Insome implementations, a first end of the stabilizer 1154 can be coupledto an impermeable layer of the assembly 1102 and a second end of thestabilizer 1154 can be coupled to a user's body (e.g., via adhesive ortape) or to an apparatus occupied by the user (e.g., a bed orwheelchair) to stabilize the position of the assembly 1102 relative to auser's urethral opening and/or the area surrounding the urethralopening. The stabilizer 1154 can be a thin, pliable strip of material.For example, in some implementations the stabilizer 1154 can includetape, gauze, cotton, cloth, or plastic. The stabilizer 1154 can be anysuitable length and/or width. In some implementations, the stabilizer1154 can be as thin as a single thread. The stabilizer 1154 can beattached to the user's body or an apparatus occupied by the user via anysuitable attachment mechanism, such as via skin-safe adhesive, tape, ahook, tying the stabilizer 1154 into a knot, or any other suitableattachment mechanism.

In some implementations, the permeable membrane can include a web offlexible porous material. For example, as shown in FIG. 16, a permeablesupport 1240 can be formed of a web of flexible porous material andshaped such that the permeable support 1240 defines a channel 1240B. Theflexible porous material can be, for example, spun plastic fibers. Thespun plastic fibers can be, for example, spun polyester fibers such asis used in a typical scouring pad. The permeable support 1240 can have atubular shape. The permeable support 1240 can be shaped such that thepermeable support 1240 is cylindrical or non-cylindrical. As shown inFIG. 17, which is a cross-section of the permeable support 1240 shown inFIG. 16 taken along the line 17-17, the channel 1240B can be shaped andconfigured to receive an outlet tube 1220.

As shown in FIG. 18, a permeable membrane 1230 can be coupled to thepermeable support 1240. The permeable membrane 1230 can be the same orsimilar in structure and/or function to any of the permeable membranesdescribed herein. The permeable support 1240 can have a first closed end1243A and a second closed end 1243B. The second closed end 1243B and thebottom of the permeable support 1240 can collectively form a reservoir1210 to collect fluid that enters the channel 1240B via the permeablemembrane 1230 and the permeable support 1240. The outlet tube 1220 canbe inserted into the channel 1240B such that fluid that travels into thepermeable support 1240 can be removed from the permeable support 1240via the channel 1240B and the outlet tube 1220 (via, for example, avacuum source).

In some implementations, a web of flexible porous material can be in theform of a flexible sheet rolled or folded into a tubular shape. Forexample, as shown in FIG. 19, a permeable support 1340 can include aflexible sheet formed of a web of flexible porous material and rolled orfolded such that the permeable support 1340 defines a channel 1340B. Theflexible porous material can be, for example, spun plastic fibers. Thespun plastic fibers can be, for example, spun polyester fibers such asis used in a typical scouring pad. The permeable support 1340 can bemade to have a tubular shape by rolling a first end of the flexiblesheet towards a second end of the flexible sheet such that the first endand the second end meet along an intersection plane identified by 1340A.The permeable support 1340 can then be secured in this shape usingsecuring elements 1352. The securing elements 1352 can include anysuitable securing element, such as, for example, adhesive or glue. Insome implementations, rather than using one or more separate securingelements 1352, the permeable support 1340 can be secured in a rolled orfolded configuration via compression from a permeable membrane (e.g.,the permeable membrane 1330 described below). The permeable support 1340can be shaped such that the permeable support 1340 is cylindrical ornon-cylindrical. As shown in FIG. 20, which is a cross-section of thepermeable support 1340 shown in FIG. 19 taken along the line 20-20, thechannel 1340B can be shaped and configured to receive an outlet tube1320.

As shown in FIG. 21, a permeable membrane 1330 can be coupled to thepermeable support 1340. The permeable membrane 1330 can be the same orsimilar in structure and/or function to any of the permeable membranesdescribed herein. For example, the permeable membrane 1330 can include awicking material wrapped around the permeable support 1340. In someimplementations, the permeable membrane 1330 can include a wickingmaterial attached or sprayed onto the web of flexible porous materialprior to folding the web into the tubular shape. The permeable support1340 can have a first closed end 1343A and a second closed end 1343B.The second closed end 1343B and the bottom of the permeable support 1340can collectively form a reservoir 1310 to collect fluid that enters thechannel 1340B via the permeable membrane 1330 and the permeable support1340. The outlet tube 1320 can be inserted into the channel 1340B suchthat fluid that travels into the permeable support 1340 can be removedfrom the permeable support 1340 via the channel 1340B and the outlettube 1320 (via, for example, a vacuum source).

FIGS. 22-26 are various views of an assembly 1402 shown in a variety ofconfigurations. As shown in FIGS. 22-24, which are a front view, backview, and side view of an assembly 1402, respectively, in someimplementations, the permeable support 1440 can be shaped as a flexiblesheet. The flexible sheet can be formed of a porous flexible web of spunplastic fibers, such as, for example, spun polyester fibers such as isused in a typical scouring pad. In some implementations, polyesterfibers are used due to their ability to remain odor free. In someimplementations, the flexible sheet can be formed of any suitable typeof fibers. An outlet tube 1420 can be attached to the permeable support1440 via any suitable attachment mechanism. For example, the outlet tube1420 can be attached to the permeable support 1440 via securementelements 1452, such as, for example, adhesive tape.

The assembly 1402 can include an impermeable layer 1450. As shown inFIG. 25, which is a side view of the assembly 1402 including theimpermeable layer 1450, the impermeable layer 1450 can be coupled to thepermeable support 1440 such that fluid traveling through the permeablesupport 1440 can be directed toward an end of the outlet tube 1420. Theimpermeable layer 1450 can, in combination with the permeable support1440, define a reservoir 1410 for collection of fluid that has enteredthe assembly 1402 via the permeable support 1440 and traveled to thebottom of the assembly 1402. For example, the bottom end of theimpermeable layer 1450 and/or the bottom end of the permeable support1440 can be a closed end such that fluid does not exit the assembly 1402except via the outlet tube 1420 (via, for example, a vacuum source).

The assembly 1402 can also include a permeable membrane 1430. As shownin FIG. 26, which is a front view of the assembly 1402, the permeablemembrane 1430 can be disposed on the outer surface of the permeablesupport 1440 or on the outer surface of the permeable support 1440 andthe backing 1450. The permeable membrane 1430 can be the same or similarto any of the permeable membranes described herein.

In some implementations, the reservoir, the impermeable layer, and/or aportion of the outlet can be formed as an integral, one piece structure.For example, FIGS. 27 and 28 are a top view and a cross-sectional sideview, respectively, of an impermeable casing 1504. The impermeablecasing 1504 includes an impermeable layer 1550, an outlet 1520, and areservoir 1510. The outlet 1520 and the reservoir 1510 are coupledtogether by the impermeable layer 1550. The impermeable layer 1550defines an elongated opening 1504A. The outlet 1520 can be configured toreceive tubing such that fluid can be removed from an interior of theimpermeable casing 1504 via the tubing. The impermeable casing 1504 canbe formed of a flexible and compliant, impermeable material, such as,for example, silicone and/or another polymer. Additionally, theimpermeable casing 1504 can be curved such that, in a configuration inwhich the impermeable casing 1504 includes a permeable membrane and/or apermeable support, the impermeable casing 1504 can expose the permeablemembrane for a comfortable and secure interface for engagement with auser's urethral opening.

In some implementations, the impermeable casing 1504 can be configuredto contain a permeable membrane disposed over a permeable support. Forexample, FIG. 29 is a top view of a permeable support 1540. Thepermeable support 1540 can define a number of inlets 1542. The inlets1542 can be symmetrical or non-symmetrical across the permeable support1540. In some implementations, the permeable support 1540 can be formedof a porous spun plastic or plastic netting material. The permeablesupport 1540 can be flexible and compliant. In some implementations, thepermeable support 1540 can be formed of flexible polypropylene, nylon,polyester, another plastic, a natural material, and/or any othersuitable material. As shown in FIG. 30, the permeable support 1540 canbe folded or rolled into a tubular shape. As shown in FIG. 31, thepermeable support 1540 can be covered with a permeable membrane 1530.For example, the permeable support 1540 can form a flexible frameworkover which the permeable membrane 1530 can fit snugly.

The permeable support 1540 in combination with the permeable membrane1530 can be disposed within the interior of the impermeable casing 1504such that the permeable support 1540 can maintain the permeable membrane1530 against or near a source of moisture (e.g., a urethral opening)through the elongated opening 1504A. The permeable membrane 1530 and thepermeable support 1540 can be positioned within the impermeable casing1504 using any suitable method. For example, in some implementations,the permeable membrane 1530 can be pulled over or wrapped around thepermeable support 1540. The combination of the permeable membrane 1530and the permeable support 1540 can then be inserted through theelongated opening 1504A of the impermeable casing 1504 and theimpermeable casing 1504 can be stretched and/or otherwise maneuveredsuch that the impermeable casing 1504 surrounds the permeable membrane1530 except in the area of the elongated opening 1504A.

In some implementations, the permeable membrane 1530 (e.g., a tubulargauze) can first be disposed over a hollow plastic pipe (not shown). Thepipe covered with the permeable membrane 1530 can be inserted throughthe opening 1520 of the impermeable casing 1504 such that the permeablemembrane 1530 is positioned within the impermeable casing 1504. Thepermeable support 1540 can then be formed into a configuration such thatthe permeable support 1540 can function as a hollow framework for thepermeable membrane 1530 (e.g., a tubular or cylindrical shape as shownin FIG. 30). The permeable support 1540 can then be inserted through thepipe and/or the opening 1520 such that the permeable support 1540 iscoextensive and arranged within the permeable membrane 1530. The pipecan then be removed from the permeable membrane 1530 and the permeablesupport 1540 via the opening 1520 while the permeable membrane 1530 andthe permeable support 1540 are grasped such that the permeable membrane1530 and the permeable support 1540 remain within the impermeable casing1504.

In some implementations, the permeable membrane 1530 (e.g., a tubulargauze) can first be disposed over a hollow plastic pipe (not shown). Thepermeable support 1540 can then be formed into a configuration such thatthe permeable support 1540 can function as a hollow framework for thepermeable membrane 1530 (e.g., a tubular or cylindrical shape as shownin FIG. 30). The permeable support 1540 can then be inserted through thepipe such that the permeable support 1540 is coextensive and arrangedwithin the permeable membrane 1530. The pipe can then be removed fromthe permeable membrane 1530 and the permeable support 1540 while thepermeable membrane 1530 and the permeable support 1540 are grasped suchthat the permeable membrane 1530 and the permeable support 1540 remainwithin the impermeable casing 1504. If the permeable membrane 1530 islonger than necessary, such as if the permeable membrane 1530 is longerthan the permeable support 1540, the permeable membrane 1530 can be cut(e.g., with scissors) to the desired length. The permeable membrane 1530in combination with the permeable support 1540 can then be inserted intothe impermeable casing 1504 via the elongated opening 1504A.

In some implementations, the permeable membrane 1530 can be attached tothe permeable support 1540 via an adhesive or adhesive tape. In someimplementations, the permeable membrane 1530 can be attached to thepermeable support 1540 via compression from the impermeable casing 1504.For example, the permeable membrane 1530 can be wrapped around thepermeable support 1540 and inserted into the impermeable casing 1504such that the impermeable casing 1504 applies compression to thepermeable membrane 1530 and the permeable support 1540 such that thepermeable membrane 1530 and the permeable support 1540 each maintaintheir shape and attachment to each other. In some implementations, thepermeable membrane 1530 can be secured to the permeable support 1540 bycompression as a result of the permeable membrane 1530 having elasticproperties. For example, the permeable membrane 1530 can include tubularcompression gauze that can be applied to the permeable support 1540 as asleeve.

FIG. 32 is a cross-sectional illustration of an assembly 1602. Theassembly 1602 includes an impermeable casing 1604. The impermeablecasing 1604 can be the same or similar in structure and/or function tothe impermeable casing 1504 described above with respect to FIGS. 27 and28. For example, the impermeable casing 1604 can include a reservoir1610, an impermeable backing 1650, and an outlet 1620. Additionally, theassembly 1602 can include a permeable membrane 1630 and a permeablesupport 1640. The permeable membrane 1630 and the permeable support 1640can be the same or similar in structure and function to and of thepermeable membranes and permeable supports, respectively, describedherein. For example, the permeable membrane 1630 can be a ribbed knitfabric sleeve and the permeable support 1640 can be formed of spunplastic (e.g., non-woven permeable webbing) shaped as a tube. Thus, theassembly 1602 can be pliable and/or flexible such that the assembly 1602can conform to differently shaped and/or sized users to ensure effectiveand secure placement of the assembly 1602. The assembly 1602 can includea tube 1621 associated with the outlet 1620 such that fluid in thereservoir 1610 can be removed through the tube 1621 and out of theoutlet 1620 via, for example, a vacuum source (not shown).

FIG. 33 is a cross-sectional side view of the assembly 1602 engaged witha female body. As shown in FIG. 33, the assembly 1602 can be arrangednear the urethra such that the elongated opening 1604A of the assembly1602 is facing the urethral opening. Additionally, the assembly 1602 canbe placed between the labia of the user and held snugly against or nearthe urethra by the pressure of friction from the user's body.Additionally, as shown in FIG. 33, the assembly 1602 can be curved suchthat the assembly 1602 provides a comfortable and secure interface forengagement with a user's urethral opening and the surrounding area ofthe user's body, with the elongated opening on the inside of the curve.Thus, upon the voiding of urine from the user's body, the urine can flowinto the assembly 1602 via the elongated opening 1604A, the permeablemembrane 1630, and an inlet of the permeable support 1640. The urine canthen flow to the reservoir 1610 of the assembly 1602 due to gravityand/or suction provided by a vacuum source via the tube 1621. Thesuction provided by the vacuum source can then draw the urine from thereservoir 1610, through the tube 1621, and out of the assembly 1602.

The assembly 1602 can have any suitable dimension such that the assembly1602 can be configured to engage with the urethral opening and/or thearea surrounding the urethral opening of users of different sizes and/oranatomical structures. For example, in some embodiments, the impermeablecasing 1604 can range from about 7 inches to about 8 inches in length(i.e. from a tip of the reservoir 1610 to the opening in the outlet1620). In some embodiments, such as for larger patients, the impermeablecasing 1604 can range from about 9 inches to about 10 inches in length.In some embodiments, such as for smaller adult patients or children, theimpermeable casing 1604 can range from about 3 inches to about 5 inchesin length. In some embodiments, the impermeable casing 1604 can rangefrom about 3 inches to about 10 inches in length. The elongated opening1604A can range from about 5 inches to about 6 inches in length. In someembodiments, the diameter of the impermeable casing 1604 can be about 1inch. In some embodiments, the diameter of the impermeable casing 1604can range from about 0.5 inches to about 1.5 inches in diameter. Theelongated opening 1604A can have a width of about 1 inch and a depth ofabout 0.5 inches relative to the height (i.e. diameter) of theimpermeable casing 1604. The permeable support 1640 can have a diameterof about 0.875 inches. The outlet 1620 can be about 0.25 inches long andabout 0.5 inches wide. The opening of the outlet 1620 can have adiameter of about 0.375 inches. Additionally, the tube 1621 can have adiameter of about 0.375 inches.

Additionally, the assembly 1602 can include any suitable curve such thatthe assembly 1602 can engage with a user's urethral opening and/or areasurrounding the urethral opening. For example, in some embodiments, theassembly 1602 and/or the impermeable casing 1604 can have an angle ofcurvature of about 40°. In some embodiments, the assembly 1602 and/orthe impermeable casing 1604 can have an angle of curvature of about 60°.In some embodiments, the assembly 1602 and/or the impermeable casing1604 can have a radius of curvature ranging from about 6 inches to about10 inches.

In some embodiments, the permeable membrane 1630 and/or the permeablesupport 1640 can be disposed fully within the impermeable casing 1604such that the permeable membrane 1630 and/or the permeable support 1640does not extend through the elongated opening 1604A. In someembodiments, the permeable membrane 1630 and/or the permeable support1640 can be disposed within the impermeable casing 1604 such that aportion of the permeable membrane 1630 and/or a portion of the permeablesupport 1640 extends through the elongated opening 1604A.

FIG. 34 is an exploded view of the components of an assembly 1802. Theassembly 1802 can be the same or similar in structure and/or function tothe assembly 1602 described above. For example, the assembly 1802includes an impermeable casing 1804. The impermeable casing 1804 can bethe same or similar in structure and/or function to the impermeablecasing 1604 and/or the impermeable casing 1504. The impermeable casing1804 can include a reservoir 1810, an impermeable backing 1850, and anoutlet 1820. Additionally, the assembly 1802 can include a permeablemembrane 1830 and a permeable support 1840. The permeable membrane 1830and the permeable support 1840 can be the same or similar in structureand function to and of the permeable membranes and permeable supports,respectively, described herein. For example, the permeable membrane 1830can be a ribbed knit fabric sleeve and the permeable support 1840 can beformed of a flexible sheet of spun plastic (e.g., non-woven permeablewebbing) that can be folded or rolled such that the permeable support1840 is shaped as a tube. Thus, the assembly 1802 can be pliable and/orflexible such that the assembly 1802 can conform to differently shapedand/or sized users to ensure effective and secure placement of theassembly 1802. The assembly 1802 can include a tube 1821 associated withthe outlet 1820 such that fluid in the reservoir 1810 can be removedthrough the tube 1821 and out of the outlet 1820 via, for example, avacuum source (not shown).

As shown in FIG. 35, which is a side view of the assembly 1802 in anassembly configuration, the permeable support 1840 can be folded orrolled such that its shape is changed from a sheet to a tube. Thepermeable membrane 1830 can be pulled over the permeable support 1840.The combination of the permeable membrane 1830 and the permeable support1840 can then be inserted through the elongated opening 1804A of theimpermeable casing 1804 and the impermeable casing 1804 can be stretchedand/or otherwise maneuvered such that the impermeable casing 1804surrounds the permeable membrane 1830 except in the area of theelongated opening 1804A. The tubing 1821 can be inserted through theoutlet 1820 such that it is disposed within a channel defined by thepermeable support 1840 with one end in the reservoir 1810. In someimplementations, the tubing 1821 can be inserted into a channel definedby the permeable support 1840 prior to inserting the permeable support1840 and the permeable membrane 1830 through the elongated opening1804A. The tubing 1821 can be threaded through the elongated opening1804A and through the opening 1820, and the reservoir 1810 of theimpermeable backing 1804 can be pulled around the opposite end of thetubing 1821, the permeable support 1840, and the permeable membrane1830.

In some implementations, an impermeable layer can define one or morevacuum relief openings. For example, FIG. 40 is a back view of animpermeable casing 2004. The impermeable casing 2004 can be the same orsimilar to the impermeable casing 1804 shown in and described withreference to FIGS. 34 and 35. The impermeable casing 2004 can include areservoir 2010, an impermeable backing 2050, and an outlet 2020. Theimpermeable casing can also include a vacuum relief opening 2058. Thus,in the event that a user's body envelopes an assembly including theimpermeable layer 2050, such as an assembly the same or similar toassembly 1802, the one or more vacuum relief openings 2058 can preventsuction from increasing against the skin of the user, which may beuncomfortable or painful. For example, the impermeable casing 2004 candefine an elongated opening (not shown) the same or similar to theelongated opening 1804A described above. The vacuum relief opening 2058can be located between two ends of the impermeable casing 2004 such thatat least one additional airflow path exists in the assembly in the eventthat the user's body obstructs a portion of or the entire elongatedopening. Although shown as being located near the outlet 2020, thevacuum relief opening 2058 can be disposed at any suitable location onthe impermeable layer 2050. In some implementations, the one or morevacuum relief openings 2058 can be disposed in a location that reducesthe likelihood that the skin of the labia or the thigh of the userinadvertently covers the hole, such as a location near the outlet 2020.Additionally, the impermeable casing 2004 can include any suitablenumber of vacuum relief openings 2058.

In some implementations, rather than including an impermeable casing, anassembly can include an impermeable backing that includes adhesive tape.For example, FIG. 36 is an exploded view of an assembly 1702. Theassembly 1702 includes a reservoir 1710, a permeable support 1740, apermeable membrane 1730, and a tube 1721. The assembly 1702 can besimilar in structure and/or function to the assembly 1602 describedabove with reference to FIGS. 32 and 33. For example, the permeablemembrane 1730 and the permeable support 1740 can be the same or similarto any of the permeable membranes and permeable supports describedherein. For example, the permeable support 1740 can be a flexible sheetof spun plastic (e.g., non-woven permeable webbing). Thus, the assembly1702 can be pliable and/or flexible such that the assembly 1702 canconform to differently shaped and/or sized users to ensure effective andsecure placement of the assembly 1702. In some implementations, thepermeable membrane 1730 can be a ribbed knit fabric sleeve.Additionally, the tube 1721 can be associated with an outlet (e.g., theoutlet 1720 in FIG. 38) for drawing fluid out of the reservoir 1710 andinto an external receptacle (such as external receptacle 160 shown anddescribed with respect to FIG. 1). The reservoir 1710 can include aflexible cap and can be configured to be attached to the permeablemembrane 1730 and/or the permeable support via an impermeable backing(e.g., the impermeable backing 1750 in FIG. 28).

As shown in FIG. 37, which is a side view of a partially assembledassembly 1702, the permeable support 1840 can be folded or rolled suchthat its shape is changed from a sheet to a tube. The permeable support1840 can then be inserted into the reservoir 1710 (e.g., a flexiblecap). The tube 1721 can be inserted through a channel formed by thepermeable support 1840 and into the reservoir 1710.

As shown in FIG. 38, the assembly 1702 can include an impermeablebacking 1750 that includes adhesive tape. The impermeable backing 1750can include two securing portions 1752A and 1752B connected by a backingportion 1753. The securing portions 1752A and 1752B in combination withthe backing portion 1753 can define an elongated opening 1704A throughwhich a fluid (e.g., urine) can travel into the assembly 1702.Additionally, the securing portion 1752A can be used to secure thereservoir 1710 to the backing portion 1753, the permeable membrane 1730,and/or the permeable support 1740 (shown in FIGS. 36 and 37). In someimplementations, the securing portion 1752B in combination with the tube1721 can form a portion of or all of the outlet 1720. Thus, theimpermeable backing 1750 can direct fluid flow through the assembly 1702such that fluid that enters the permeable membrane 1730 and thepermeable support 1740 via the elongated opening 1704A does not exit theassembly 1702 except via the tube 1721. In use, the fluid can flow dueto gravity and/or suction toward the reservoir 1710 and be contained bythe reservoir 1710 and the impermeable backing 1750. The tube 1721 canthen be used to draw the fluid out of the assembly 1702 (via, forexample, a vacuum source). Additionally, the impermeable backing 1750can assist in limiting the area of the permeable membrane 1730experiencing suction from a vacuum source such that the pressuredifferential is stronger and fluid can be drawn through the permeablemembrane 1730 efficiently.

FIG. 39 is a flowchart illustrating a method of using an assembly tocollect urine from a user, according to an embodiment. The method 1900optionally includes, at 1902, fluidically coupling the discharge end ofthe tube of the urine collecting apparatus to a fluid receptacle. Method1900 optionally further includes, at 1904, fluidically coupling thedischarge end of the tube of the urine collecting apparatus to a sourceof vacuum. Method 1900 further includes, at 1906, disposing in operativerelationship with the urethral opening of a female user (e.g. human oranimal) the urine collecting apparatus. The urine collecting apparatuscan be the same or similar in structure and/or function to any of theurine collecting apparatus described herein, such as, for example, theassembly 102 in FIG. 1. For example, the urine collecting apparatus caninclude a fluid impermeable casing, a fluid permeable support, a fluidpermeable membrane, and a tube. The fluid impermeable casing can have afluid reservoir at a first end and a fluid outlet at a second end. Alongitudinally extending fluid impermeable layer can be coupled to thefluid reservoir and the fluid outlet and can define a longitudinallyelongated opening between the fluid reservoir and the fluid outlet. Thefluid permeable support can be disposed within the casing with a portionextending across the elongated opening. The fluid permeable membrane canbe disposed on the support and can cover at least the portion of thesupport that extends across the elongated opening, so that the membraneis supported on the support and disposed across the elongated opening.The tube can have a first end disposed in the reservoir and a secondfluid discharge end. The tube can extend behind at least the portion ofthe support and the portion of the membrane disposed across theelongated opening and can extend through the fluid outlet to the secondfluid discharge end. The operative relationship can include the openingbeing adjacent to the urethral opening of the female user.

The method 1900 also includes, at 1908, allowing urine discharged fromthe urethral opening to be received through the opening of the fluidimpermeable layer, the membrane, the support, and into the reservoir.

The method 1900 also includes, at 1910, allowing the received urine tobe withdrawn from the reservoir via the tube and out of the fluiddischarge end of the tube.

The method 1900 optionally includes, at 1912, removing the urinecollecting apparatus from the operative relationship with the urethralopening of the user.

Finally, the method 1900 optionally includes, at 1914, disposing asecond urine collecting apparatus in operative relationship with theurethral opening of the user.

In some embodiments, the support and casing can be cylindrical and canhave a curved shape with the elongated opening disposed on the inside ofthe curve. The disposing can include disposing the urine collectingapparatus with the elongated opening adjacent the urethral opening ofthe user and oriented with the reservoir proximal to the user's anus andthe outlet disposed above the urethral opening.

In some embodiments, an assembly (such as, for example, the assembly1602 shown in FIG. 32) can have a curved shape that is defined ormaintained at least in part by a shape-retaining member. In someembodiments, the shape-retaining member can be implemented as a tubewith an intake end positioned within a reservoir such that the tubeextends from the reservoir and through at least a portion of a permeablesupport, similar to, for example, the tube 1621 shown with respect toFIGS. 32 and 33, that has a precurved shape such that at least a portionof an assembly including the tube will also have a similar orcorresponding precurved shape. For example, as shown in FIG. 41, a tube2121 is precurved. The tube 2121 can be the same or similar in structureand/or function to any of the tubes described herein, such as the tube1621, the tube 1721, and/or the tube 1821. The tube 2121 can beprecurved to any suitable curved shape (e.g., any suitable angle ofcurvature) such that, for example, an assembly including the tube 2121can engage with a user's urethral opening and/or an area surrounding theurethral opening.

In some implementations, the tube 2121 can be initially formed such thatit has an uncurved (i.e., straight) overall shape. The tube 2121 canthen be curved via, for example, heat setting. Said another way, thetube 2121 can be formed of a stiff or rigid material, such as a stiffplastic, in a straight shape. The tube 2121 can be heated such that thetube 2121 is softened, and then the tube 2121 can be bent to apredefined curved shape. After being curved, the tube 2121 can be cooledsuch that the tube 2121 hardens.

In some implementations, the tube 2121 can be precurved by initiallyforming the tube 2121 such that the tube 2121 has a straight shape andthen bending the tube 2121 beyond the elastic limit of the tube 2121such that the tube 2121 has a preset curve. For example, the tube 2121can be formed of a material such as metal that will retain a curvedshape after being bent to the curved shape.

In some embodiments, an assembly (such as, for example, the assembly1602 shown in FIG. 32) can have a curved shape that is defined ormaintained at least in part by a shape-retaining member that is separatefrom the tube that has an intake end in the reservoir. Thus, theassembly can have both a tube and a separate shape-retaining element formaintaining the assembly or a portion of the assembly in a precurvedshape. For example, as shown in FIG. 42, a shape-retaining element 2251can have a precurved shape. The shape-retaining element 2251 can beformed of, for example, a strip of semi-rigid material. Theshape-retaining element 2251 can be attached to any suitable portion ofthe assembly. For example, in some implementations, the shape-retainingelement 2251 can be attached to an inner surface of an impermeablelayer, such as impermeable layer 1650. In some implementations, theshape-retaining element 2251 can be disposed between an impermeablelayer (e.g., the impermeable layer 1650) and a permeable support (e.g.,the permeable support 1640) and/or a permeable membrane (e.g., thepermeable membrane 1630). In some implementations, the shape-retainingelement 2251 can be attached to an outer surface of an impermeable layer(e.g., the impermeable layer 1650) or can be imbedded in an impermeablelayer (e.g., the impermeable layer 1650).

In some embodiments, a tube with an intake end positioned within areservoir such that the tube extends from the reservoir and through atleast a portion of a permeable support, similar to, for example, thetube 1621 shown with respect to FIGS. 32 and 33, can have a beveledintake end (i.e. a beveled reservoir end). As shown in FIG. 43, a tube2321 includes a beveled intake end 2323. The tube 2321 can be thesimilar in structure and/or function to any of the tubes describedherein, such as, for example, the tube 1621, the tube 1721, the tube1821 and/or the tube 2121. The beveled intake end 2323 can preventblockage of the tube 2321 in operation. For example, the beveled intakeend 2323 can increase the size of an intake opening 2325 of the tube2321 such that the intake opening 2325 is less likely to be blocked byan obstruction. Additionally, the beveled intake end 2323 can preventthe tube 2323 from becoming obstructed at the intake end by the materialforming the reservoir. For example, in assemblies in which the reservoiris formed by a flexible and/or pliable material as part of a casing,such as the reservoir 1810 of casing 1804 in FIG. 35, the suctionresulting from the vacuum through the tube 1821 and/or force applied tothe outside of the reservoir may cause the material of the reservoir1810 to move toward the intake end of the tube 1821 and obstruct and/orseal the intake end of the tube 1821, preventing the flow of fluidthrough the intake end of the tube 1821. A beveled intake end of thetube 2321 can prevent this obstruction from occurring due to the angledtip. Even if a portion of a reservoir (e.g., 1810) flexes into contactwith the distal end of the tube 2321, the intake opening 2325 can remainat least partially or completely unobstructed.

In some embodiments, an assembly can include a casing that includes achannel defined in a sidewall of the casing, instead of the tubeextending within the casing, as disclosed in many of the previousembodiments. For example, FIG. 44A is a cross-sectional side view of acasing 2404. The casing 2404 can be similar in structure and/or functionto any of the casings described herein, such as, for example, the casing1604 shown in FIG. 32. For example, casing 2404 can include a reservoir2410 and an impermeable backing 2450. The casing 2404 can include aclosed end 2499 opposite the reservoir 2410. In some embodiments, asshown in FIG. 44A, the casing 2404 can include an impermeable externalwall 2451, such that the impermeable backing 2450 and the external wall2451 collectively define a channel 2490. For example, FIG. 44B, which isa schematic illustration of a cross-section of the casing 2404 takenalong the line 44B-44B in FIG. 44A, shows the channel 2490 definedbetween the external wall 2451 and the impermeable backing 2450. Theimpermeable backing 2450 can define an opening 2480 such that thechannel 2490 can be in fluidic communication with the reservoir 2410 viathe opening 2480. For example, FIG. 44C, which is a schematicillustration of a cross-section of the casing 2404 taken along the line44C-44C in FIG. 44A, shows the opening 2480 defined in the impermeablebacking 2450 such that fluid can flow from the reservoir 2410, throughthe opening 2480, and into the channel 2490. Although FIGS. 44A-44D showthe opening 2480 disposed at the point of line 44C-44C (i.e., near or inthe reservoir 2410), in some embodiments one or more openings similar instructure and/or function to opening 2480 can be disposed at one or moreother positions along the impermeable backing 2450 that are suitable forforming a fluidic connection between the channel 2490 and the reservoir2410. FIG. 44D, which is a schematic illustration of a bottom view ofthe impermeable backing 2450 (i.e., without the external wall 2451attached), similarly shows the opening 2480 defined in the impermeablebacking 2450 near the reservoir 2410.

The channel 2490 can extend along the length of the casing 2404, asshown, from the opening 2480 to an outlet 2420 such that fluid in thereservoir 2410 can be removed via the opening 2480 through the channel2490 via, for example, a vacuum source (not shown) coupled to the outlet2420. Although shown as having a crescent shape, the channel 2490 can beformed in any suitable shape. For example, the channel 2490 can betubular. In some implementations, as shown in FIG. 44A, a tube 2429 canbe coupled to or integrally formed with the casing 2404 such that thetube 2429 defines an additional length of the channel 2490 and thus theoutlet 2420 is disposed at a distance from the impermeable backing 2450.In some implementations, the outlet 2420 may be disposed proximal to theclosed end 2499 of the casing. In some implementations, the tube 2429and the other components of the casing 2404 can be formed as anintegral, one-piece structure, as shown in FIG. 44A. In someimplementations, the external wall 2451 at least partially defining thechannel 2490 and/or the tube 2429 can be separately formed and attachedto the impermeable backing 2450 and/or the closed end of the casing 2499via, for example, adhesive or tape.

The casing 2404 can be made from material similar in structure and/orfunction to any of the casings described herein, such as, for example,the casing 1504 shown in FIG. 27, the casing 1604 in FIG. 32 and/or thecasing 1804 shown in FIG. 35, such that the assembly can withstand thepressure differential needed to draw fluid voided from the urethralopening of a user into a permeable support (not shown) housed within thecasing 2404 and into the reservoir 2410 without collapsing. The casing2404, the channel 2490 and/or the tube 2429 may include spines or othersuitable structures to reinforce their structural integrity. The casing2404, and in particular the impermeable backing 2450 and the externalwall 2451 defining the channel 2470, can be made of a material andformed so as to be able to withstand the pressure differential needed toremove collected fluid from the reservoir 2410 through the channel 2490via the opening 2480, through the outlet 2420, and into an externalreceptacle (not shown). Thus, the impermeable backing 2450 and theexternal wall 2451 can be made of a material sufficiently strong orrigid such that the channel 2490 can remain open and unobstructed whencoupled to a vacuum source.

In some embodiments, rather than the channel being collectively definedby an external wall and an impermeable backing, the assembly can includean external tube defining a channel. For example, FIG. 45 is across-sectional illustration of an assembly 2500. The assembly 2500 caninclude a casing 2504. The casing 2504 can be similar in structureand/or function to any of the casings described herein, such as, forexample, the casing 2404 shown in FIG. 44A. For example, casing 2504 caninclude a reservoir 2510 and an impermeable backing 2550. The casing2504 can include a closed end 2599 opposite the reservoir 2510. Theimpermeable backing 2550 and/or the reservoir 2510 can define an opening2580. The assembly 2500 can include an outlet tube 2528 defining alumen. The outlet tube 2528 can be disposed on the casing 2504 such thatthe outlet tube 2528 extends from the opening 2580 and the lumen of theoutlet tube 2528 is in fluid communication with the opening 2580 and thereservoir 2510. The outlet tube 2528 may be made of flexible or rigidmaterial. The casing 2504 and the outlet tube 2528 can be formedtogether as an integral piece or formed separately and connected usingany suitable coupling mechanism such as, for example, tube fittings,adhesive, and/or tape. Although in the embodiment shown in FIG. 45 theopening 2580 is disposed in the reservoir 2510, in other embodiments oneor more openings similar in structure and/or function to the opening2580 can be disposed at other position(s) along the impermeable backing,and an outlet tube such as the outlet tube 2528 can be coupled to eachof the one or more openings.

In some implementations, the assembly 2500 can include an external tube2522 defining a channel. The outlet tube 2528 can be coupled to theexternal tube 2522 such that the channel of the external tube 2522 is influidic communication with the lumen of the outlet tube 2528 (and, thus,the reservoir 2510). The outlet tube 2528 can have any suitable lengthfor fluidically coupling the reservoir 2510 with the external tube 2522.The outlet tube 2528 can be secured to the external tube 2522 using anysuitable coupling mechanism such as, for example, a leak-proof tubeconnecting apparatus, adhesive, and/or tape. In some implementations,the external tube 2522 can be fluidically coupled to a vacuum source(not shown) such that fluid can be evacuated from the reservoir 2510 viasuction created by the vacuum source. The outlet tube 2528 (and thecasing 2504 if formed integrally with tube 2528) can be made frommaterial similar in structure and/or function to any of the casingsdescribed herein, such as, for example, the casing 2404 shown in FIG.44A, such that the assembly can withstand the pressure differentialneeded to draw urine voided from the urethral opening of a user into apermeable support (not shown) housed within the casing 2504, into thereservoir 2510, through the outlet tube 2528 via the opening 2580, andthrough the external tube 2522 connected to an external receptacle (notshown).

In some embodiments, rather than including a permeable membrane disposedon a permeable support, the permeable support can be formed of amaterial that provides the functions of both the permeable membrane andthe permeable support. For example, FIGS. 46 and 47 are a side view andan exploded view, respectively, of an assembly 2602, according to anembodiment. The assembly 2602 includes a permeable support 2640, a tube2621, and a casing 2604. The permeable support 2640 can be formed of amaterial that includes the at least some of the features and/or providesat least some of the functions of both the permeable membrane andpermeable support of embodiments described above. The assembly 2602 canotherwise be the same or similar in structure and/or function to the anyof the embodiments described above. For example, the impermeable casing2604 can be the same or similar in structure and/or function to theimpermeable casings 1504, 1604, 1804, 2004, 2404, and/or 2504. Theimpermeable casing 2604 can include a reservoir 2610, an impermeablebacking 2650, and an outlet 2620. Additionally, the impermeable casing2604 can define an elongated opening 2604A.

As noted above, the permeable support 2640 can be the same or similar infunction to the permeable membranes and/or the permeable supports,respectively, described in the previous embodiments. The permeablesupport 2640, however, can be formed of a single material that meets thefunctional requirements and/or includes the functional benefits of thematerials of both the permeable membranes and the permeable supports ofthe previous embodiments. Specifically, the material of which permeablesupport 2640 is formed can have sufficient structural integrity to serveas a permeable support for the casing 2604, sufficient porosity and/orpermeability to allow urine to pass freely through the permeable support2640, and/or sufficient loft and resiliency to extend to or out of theelongated opening 2604A. The permeable support 2640 can also besufficiently pliable and/or flexible such that the assembly 2602 canconform to differently shaped and/or sized users to ensure effective andsecure placement of the assembly 2602.

In addition, the material of which the permeable support 2640 is formedcan have an exterior surface that provides the same functions as thepermeable membranes of the previous embodiments. Thus, the permeablesupport 2640 can be urine permeable and can have wicking properties.Specifically, the permeable support 2640 can have a high absorptive rateand a high permeation rate such that urine can be rapidly absorbedand/or transported therethrough. The permeable support 2640 can be softand/or minimally abrasive such that it does not irritate the skin of theuser. Additionally, the permeable support 2640 can wick fluid away fromthe urethral opening and/or the skin of the user such that the dampnessof the skin of the user is lessened and infections are prevented. Thepermeable support 2640 can also be sufficiently permeable and/or havesufficient wicking ability to help prevent urine from leaking or flowingbeyond the assembly onto, for example, a bed.

The material of which the permeable support 2640 is formed can be in theform of a flexible sheet rolled or folded into a tubular form, forexample, as shown in FIG. 47 and in the illustration in FIG. 48.Alternatively, the permeable support 2640 can be formed as a cylindersuch that the permeable support 2640 has the desired shape withoutrolling or folding. The permeable support 2640 can be made from, forexample, polyester, recycled polyester fleece, and/or nylon knit mesh.The permeable support 2640 can be secured within a hollow casing (forexample, the casing 2604 shown in FIGS. 46 and 47) by inserting thepermeable support 2640 into the casing via an elongated opening of thecasing (e.g., elongated opening 2604A of the casing 2604). In someimplementations, the permeable support 2640 may be affixed to a casingsuch as the casing 2604 by using any suitable means, such as, forexample, using adhesive, glue, and/or tape.

In use, once inserted and positioned against the impermeable backing2650, the assembly 2602 may be positioned relative to a user such thatthe surface of the permeable support 2640 contacts the urethral openingof the user. Urine can be drawn through the permeable support 2640 suchthat the urine collects in the reservoir 2610. The urine can then bedrawn from the reservoir 2610 via the tube 2621 and through the outlet2620 using, for example, an external vacuum source (not shown). Thematerial of which permeable support 2640 is formed may be compressible.The material can also have sponge-like properties such that the materialcan maintain shape when wet, thereby maintaining contact with the userduring a urination event via a slight protrusion of the permeablesupport 2640 outside the casing 2604 via the elongated opening 2604A.While the permeable support 2640 is shown with casing 2604 in FIGS. 46and 47 for illustration purposes, the permeable support 2640 can be usedin conjunction with any of the assemblies or casings shown or describedherein, such as, for example, the assembly 802 of FIG. 9, the assemblyof FIG. 18, the casing 1504 of FIG. 27, the casing 1604 of FIG. 32, thecasing 1804 of FIGS. 34-35, the assembly 1702 of FIGS. 37-38, the casing2004 of FIG. 40, the casing 2404 of FIG. 44A, and/or the casing 2504 inFIG. 45.

In some embodiments, rather than including an outlet tube as shown anddescribed with respect to assembly 2500 in FIG. 45, an assembly caninclude an outlet tube inserted partially into the reservoir andextending away from the assembly. For example, FIG. 49A is a lengthwisecross-sectional view of an assembly 2702. The assembly 2702 can includea casing 2704, a permeable support 2740, and a permeable membrane 2730.The assembly 2702 can be similar in structure and/or function to any ofthe assemblies described herein, such as, for example, the assembly 102shown and described with respect to FIG. 1, the assembly 1802 shown anddescribed with respect to FIG. 35, and/or the assembly 2602 shown anddescribed with respect to FIG. 46. Specifically, the casing 2704 can besimilar in structure and/or function to any of the casings describedherein, such as, for example, the casing 1504 shown and described withrespect to FIGS. 27 and 28, the casing 1804 shown and described withrespect to FIG. 34, the casing 2004 shown and described with respect toFIG. 40, the casing 2404 shown and described with respect to FIG. 44Aand/or the casing 2504 shown and described with respect to FIG. 45. Thecasing 2704 can include, for example, an impermeable backing 2750, areservoir 2710, a closed end 2799 opposite the reservoir 2710, and anopening 2780 defined by the impermeable backing 2750 and/or thereservoir 2710. The casing 2704 can be made with or without a precurvedform. For example, in some implementations, the casing 2704 can beprecurved such that the casing 2704 is concave or convex. Although shownas including a separate permeable membrane 2730 and permeable support2740, in some embodiments the assembly 2702 can include a permeablesupport 2740 made of a material such that the permeable support 2740 caninclude some or all of the functions of any of the permeable membranesdescribed herein. In such embodiments, the assembly 2702 can includeonly a permeable support and not a separate permeable membrane disposedon the permeable support.

The assembly 2702 can include an outlet tube 2726 that can be insertedinto the casing 2704 through the opening 2780 such that the insertedopen end of the tube 2726 can be disposed within the reservoir 2710. Insuch an arrangement, a lumen of the tube 2726 can be in fluidiccommunication with the reservoir. An exemplary casing 2704 with amounted outlet tube 2726 is shown in cross-sectional view in FIG. 49B.The outlet tube 2726 can be made of flexible or rigid material. As shownin FIG. 49B and in the cross-sectional view taken along line 49C-49Cshown in FIG. 49C, the outlet tube 2726 can extend along the outside ofand away from the casing 2704. The outlet tube 2726 can have anysuitable length such that the outlet tube 2726 is suitable for theextraction of fluid from the reservoir 2710. The outlet tube 2726 can besecured to the casing 2704 through any leak-proof coupling mechanism,for example by using pressure insertion through the opening 2780, or byusing the stiction properties of the tube 2726 and the casing 2704. Insome implementations, the outlet tube 2726 can be secured to the casing2704 due to the reservoir end of the outlet tube 2726 having a largerdiameter than the opening 2880A. In some implementations, the outlettube 2726 can be secured to the casing 2704 via, for example, aleak-proof fastening mechanism such as, for example, adhesive and/ortape. In some implementations, the outlet tube 2726 can be directlycoupled to an external receptacle (e.g., the external receptacle 160)such that urine collected in the reservoir can be transported to theexternal receptacle via the outlet tube 2726. In some implementations,the outlet tube 2726 can be coupled to an external receptacle viaanother tube (not shown) coupled to the outlet tube 2726. In someimplementations, a vacuum source can be used to assist in drawing fluidfrom the reservoir 2710 via the outlet tube 2726.

Although FIG. 49A shows the opening 2780 disposed in or near thereservoir 2710, in other embodiments one or more openings similar instructure and/or function to the opening 2780 can be disposed at one ormore other positions along the length of the impermeable backing 2750 aswell as laterally along the width of the impermeable backing 2750 suchthat a tube such as the outlet tube 2726 can be inserted and secured ineach of the one or more openings of the casing 2704. For example, asshown in FIG. 50A, the assembly 2802 includes a first tube 2826A and asecond tube 2826B. The assembly 2802 can be similar in structure and/orfunction to any of the assemblies described herein. For example, theassembly 2802 can include a casing 2804 defining an elongated opening2804A, an impermeable backing 2850, a reservoir 2810, and a closed end2899 opposite the reservoir end. FIG. 51 shows a shallow angledperspective view of the assembly 2802 with the first tube 2826A and thesecond tube 2826B coupled to the casing 2804. As shown in FIGS. 50A and51, the casing 2804 can define a first opening 2880A and a secondopening 2880B (shown in FIG. 51) defined in the impermeable backing 2850through which the first tube 2826A and the second tube 2826B,respectively, can be inserted. For example, as shown in phantom in FIG.50A, the reservoir end of the tube 2826A can be inserted through theopening 2880A into the reservoir 2810. The portion of each of the firsttube 2826A and the second tube 2826B disposed within the casing can beof any suitable length that allows proper extraction of fluid collectedin the reservoir without any obstruction to the open tips of the firsttube 2826A and the second tube 2826B. The open tips of the first tube2826A and the second tube 2826B can be disposed within the reservoir2810 such that fluid can flow from the reservoir 2810 during use withoutobstruction or interference by the casing 2804 with the assistance of,for example, vacuum suction or gravity.

In some implementations, the two openings 2880A and 2880B can bedisposed at any suitable location along the length and width of thecasing 2804 such that there may be sufficient spatial separation betweenthe reservoir ends of the first tube 2826A and the second tube 2826B formaximal and effective extraction of urine collected in the reservoir2810 during use of the assembly 2802. Additionally, the two openings2880A and 2880B may be positioned such that proper coupling between thefirst tube 2826A, the second tube 2826B, and the casing can be ensured.

The assembly 2802 can be fashioned such that the outlet tubes 2826A and2826B extend along the outside of the casing 2804 as shown in FIG. 50B,which is a cross-sectional view taken along the line 50B-50B in FIG.50A. The assembly 2802 can include a permeable support 2840 and apermeable membrane 2830, and can be positioned such that a portion ofthe permeable membrane 2830 extends through the elongated opening 2804Aand against or near the urethral opening of the user. In someimplementations, the tubes 2826A and 2826B can be directly coupled to anexternal receptacle (e.g., the external receptacle 160) such that urinecollected in the reservoir can be transported to the external receptaclevia the tubes 2826A and 2826B. In some implementations, the tubes 2826Aand 2826B can be coupled to an external receptacle via an external tube2822 (shown in FIG. 51) coupled to the tubes 2826A and 2826B. The tubes2826A and 2826B can be connected to the external tube 2822 using anycoupling mechanism that allows leak-proof connection, such as, forexample, tube fittings, adhesive, or tape. In some implementations, avacuum source can be used to assist in drawing fluid from the reservoir2810 via the tubes 2826A and 2826B. The positioning, structure andmaterial of the tubes 2826A and 2826B, external tube 2822, and thecasing 2804 can be such that the assembly 2802 allows for free flow offluid from a urethral opening of a user, through the permeable membrane2830, through the permeable support 2840, into the reservoir 2810,through the openings 2880A and 2880B, and through the tubes 2826A and2826 without obstruction of the open reservoir ends of the tubes 2826Aand 2826B. Additionally, the assembly 2802 can withstand the pressuredifferential due to the application of vacuum suction to draw out thefluid (e.g., urine) collected in the reservoir 2810. The assembly 2802can also simultaneously be sufficiently pliable and/or flexible toconform to the size and shape of different users to ensure effectivetransfer of voided urine.

Although the assembly 2802 is shown to include a permeable support 2840(indicated by the dot pattern) and a permeable membrane 2830 (indicatedby a cross pattern) in FIG. 50B, in other embodiments the assembly mayinclude a permeable support 2840 made of material such that it servesthe functions of both the permeable support and the permeable membrane.Such a permeable support 2840 can be similar in structure and/orfunction to permeable support 2640 in assembly 2602. For example, thepermeable support 2840 can have an exterior surface with wickingproperties, a high absorptive rate, and/or a high permeation rate suchthat urine can be rapidly absorbed and/or transported therethrough.Further, the permeable support 2840 can be soft and/or minimallyabrasive such that the exterior surface of the permeable support 2840does not irritate the skin of the user. The permeable support 2840 canalso be made of a material that can wick fluid away from the urethralopening and/or the skin of the user such that the dampness of the skinof the user is lessened and infections are prevented.

While various embodiments of the system, methods and devices have beendescribed above, it should be understood that they have been presentedby way of example only, and not limitation. Where methods and stepsdescribed above indicate certain events occurring in certain order,those of ordinary skill in the art having the benefit of this disclosurewould recognize that the ordering of certain steps may be modified andsuch modifications are in accordance with the variations of theinvention. Additionally, certain of the steps may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above. The embodiments have been particularlyshown and described, but it will be understood that various changes inform and details may be made.

For example, although various embodiments have been described as havingparticular features and/or combinations of components, other embodimentsare possible having any combination or sub-combination of any featuresand/or components from any of the embodiments described herein. Inaddition, the specific configurations of the various components can alsobe varied. For example, the size and specific shape of the variouscomponents can be different than the embodiments shown, while stillproviding the functions as described herein.

1. An apparatus comprising: a fluid impermeable casing having a fluidreservoir at a first end, a fluid outlet at a second end, and alongitudinally extending fluid impermeable layer coupled to the fluidreservoir and the fluid outlet and defining a longitudinally elongatedopening between the fluid reservoir and the fluid outlet; a fluidpermeable support disposed within the casing with a portion extendingacross the elongated opening; a fluid permeable membrane disposed on thesupport and covering at least the portion of the support that extendsacross the elongated opening, so that the membrane is supported on thesupport and disposed across the elongated opening; a tube having a firstend disposed in the reservoir and extending behind at least the portionof the support and the portion of the membrane disposed across theelongated opening and extending through the fluid outlet to a second,fluid discharge end, the apparatus configured to be disposed with theopening adjacent to a urethral opening of a user, to receive urinedischarged from the urethral opening through the opening of the fluidimpermeable layer, the membrane, the support, and into the reservoir,and to have the received urine withdrawn from the reservoir via the tubeand out of the fluid discharge end of the tube.
 2. The apparatus ofclaim 1, wherein the casing is integrally formed of a polymer material.3. The apparatus of claim 1, wherein the reservoir is formed of polymerand the fluid impermeable layer and fluid outlet are formed of elongatestrips of adhesive tape.
 4. The apparatus of claim 1, wherein thesupport is cylindrical and defines a lumen, the membrane is a fabricsleeve disposed around the support, and the tube is disposed in thelumen of the support.
 5. The apparatus of claim 1, wherein the supportand casing are substantially cylindrical, the apparatus configured tobe: disposed with the elongated opening adjacent the urethral opening ofa human female; oriented with the reservoir adjacent to the user's anusand the outlet disposed above the urethral opening; and arranged with acurved shape with the elongated opening disposed on the inside of thecurve.
 6. The apparatus of claim 1, wherein the support is formed ofspun plastic and the membrane is formed of ribbed knit fabric.
 7. Theapparatus of claim 1, further comprising a fluid receptacle fluidicallycoupled to the discharge end of the tube.
 8. The apparatus of claim 1,further comprising a source of vacuum fluidically coupled to thedischarge end of the tube. 9.-57. (canceled)
 58. An apparatuscomprising: a fluid impermeable casing defining a fluid reservoir at afirst end, a fluid outlet at a second end, and a longitudinallyextending portion extending between the fluid reservoir and the fluidoutlet and defining a longitudinally elongated opening between the fluidreservoir and the fluid outlet; a fluid permeable support disposedwithin the casing with a portion extending across the elongated opening;a fluid permeable membrane disposed on the support and covering at leastthe portion of the support that extends across the elongated opening, sothat the membrane is supported on the support and disposed across theelongated opening; a tube having a first end disposed in the reservoirand extending behind at least the portion of the support and the portionof the membrane disposed across the elongated opening and extendingthrough the fluid outlet to a second, fluid discharge end, the apparatusconfigured to: be disposed with the opening adjacent to a urethralopening of a user, with the fluid permeable membrane engaging tissuesurrounding the urethral opening, be retained in position on the usersolely by frictional engagement with and/or between the labia and/orother portions of the area of the user's body surrounding the urethralopening, and receive urine discharged from the urethral opening throughthe opening of the fluid impermeable layer, the membrane, the support,and into the reservoir, and to have the received urine withdrawn fromthe reservoir via the tube and out of the fluid discharge end of thetube.
 59. The apparatus of claim 58, wherein the apparatus is configuredto be retained in position on the user via engagement between the firstend of the casing and a user's perineum. 60.-61. (canceled)
 62. Anapparatus comprising: a fluid impermeable casing defining a fluidreservoir at a first end, a fluid outlet at a second end, and alongitudinally extending portion extending between the fluid reservoirand the fluid outlet and defining a longitudinally elongated openingbetween the fluid reservoir and the fluid outlet; a fluid permeablesupport disposed within the casing with a portion extending across theelongated opening; a fluid permeable membrane disposed on the supportand covering at least the portion of the support that extends across theelongated opening, so that the membrane is supported on the support anddisposed across the elongated opening; a tube having a first enddisposed in the reservoir and extending behind at least the portion ofthe support and the portion of the membrane disposed across theelongated opening and extending through the fluid outlet to a second,fluid discharge end, the tube having only a first opening at the firstend and a second opening at the second end, and a lumen fluidicallycoupling the first opening and the second opening, the apparatusconfigured to be disposed with the opening adjacent to a urethralopening of a user, with the fluid permeable membrane engaging tissuesurrounding the urethral opening, to receive urine discharged from theurethral opening through the opening of the fluid impermeable layer, themembrane, the support, and into the reservoir, and to have the receivedurine withdrawn from the reservoir via the tube and out of the fluiddischarge end of the tube.
 63. (canceled)
 64. An apparatus comprising: afluid impermeable casing defining a pliable fluid reservoir at a firstend, a fluid outlet at a second end, and a longitudinally extendingportion extending between the fluid reservoir and the fluid outlet anddefining a longitudinally elongated opening between the fluid reservoirand the fluid outlet; a fluid permeable support disposed within thecasing with a portion extending across the elongated opening; a fluidpermeable membrane disposed on the support and covering at least theportion of the support that extends across the elongated opening, sothat the membrane is supported on the support and disposed across theelongated opening; a tube having a first end with a first openingtherein disposed in the reservoir and extending behind at least theportion of the support and the portion of the membrane disposed acrossthe elongated opening and extending through the fluid outlet to asecond, fluid discharge end, the apparatus configured to be disposedwith the opening adjacent to a urethral opening of a user, with thefluid permeable membrane engaging tissue surrounding the urethralopening, to receive urine discharged from the urethral opening throughthe opening of the fluid impermeable layer, the membrane, the support,and into the reservoir, and to have the received urine withdrawn fromthe reservoir via the tube and out of the fluid discharge end of thetube by a vacuum-induced pressure differential at the first end of thetube sufficiently large to withdraw urine through the tube at flow rateapproximately equal to the urine discharge rate in a typical urinationevent and without causing the fluid reservoir to be drawn towards and toocclude the first opening in the first end of the tube. 65.-66.(canceled)